Junifen may be available in the countries listed below.
Ingredient matches for Junifen
Ibuprofen
Ibuprofen is reported as an ingredient of Junifen in the following countries:
- Belgium
- Luxembourg
- Spain
International Drug Name Search
Tuesday, July 31, 2012
Saturday, July 28, 2012
Zovia 1/35
Generic Name: ethinyl estradiol and ethynodiol diacetate (ETH in ill ESS tra DYE ol and ETH in o DYE ol dye AS e tate)
Brand Names: Kelnor, Zovia 1/35, Zovia 1/50
What is Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate)?
Ethinyl estradiol and ethynodiol diacetate contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Ethinyl estradiol and ethynodiol diacetate are used as contraception to prevent pregnancy.
Ethinyl estradiol and ethynodiol diacetate may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate)?
Do not use this medication if you are pregnant or if you have recently had a baby or if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.
Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.
What should I discuss with my healthcare provider before taking Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate)?
This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:
a history of a stroke, blood clot, or circulation problems;
a hormone-related cancer such as breast or uterine cancer;
abnormal vaginal bleeding;
liver disease or liver cancer; or
a history of jaundice caused by birth control pills.
Before using this medication, tell your doctor if you have any of the following conditions.
high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
high cholesterol or if you are overweight;
kidney disease;
a history of depression;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles;
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;
uterine fibroid tumors;
varicose veins; or
tuberculosis.
The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.
How should I take Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate)?
Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.
Store this medication at room temperature away from moisture and heat.
What happens if I miss a dose?
Missing a pill increases your risk of becoming pregnant.
If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.
If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.
If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.
If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
What should I avoid while taking Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate)?
Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.
Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
headache, nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Zovia 1/35 (ethinyl estradiol and ethynodiol diacetate)?
Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:
acetaminophen (Tylenol) or ascorbic acid (vitamin C);
phenylbutazone (Azolid, Butazolidin);
St. John's wort;
an antibiotic;
seizure medications;
a barbiturate sedative; or
HIV or AIDS medications.
This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Zovia 1/35 resources
- Zovia 1/35 Side Effects (in more detail)
- Zovia 1/35 Use in Pregnancy & Breastfeeding
- Drug Images
- Zovia 1/35 Drug Interactions
- Zovia 1/35 Support Group
- 3 Reviews for Zovia/35 - Add your own review/rating
- Kelnor Prescribing Information (FDA)
Compare Zovia 1/35 with other medications
- Abnormal Uterine Bleeding
- Birth Control
- Endometriosis
- Gonadotropin Inhibition
Where can I get more information?
- Your pharmacist can provide more information about ethinyl estradiol and ethynodiol diacetate.
See also: Zovia/35 side effects (in more detail)
MASTAFLU
1. Name Of The Medicinal Product
MASTAFLU®, suspension for injection (influenza vaccine, surface antigen, inactivated)
2. Qualitative And Quantitative Composition
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strains:
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per 0.5 ml dose.
* propagated in hens' eggs
** haemagglutinin
This vaccine complies with the WHO recommendation (northern hemisphere), and the decision of the EU for the 2006/2007 season.
For excipients, see 6.1.
3. Pharmaceutical Form
Suspension for injection in pre-filled syringes.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
4.2 Posology And Method Of Administration
Adults and children from 36 months: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited; doses of 0.25 ml or 0.5 ml have been used.
For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
4.3 Contraindications
Hypersensitivity to the active substances, to any of the excipients and to eggs, chicken protein (MASTAFLU does not contain more than 1 microgram ovalbumin per dose), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.
Immunisation shall be postponed in patients with febrile illness or acute infection.
4.4 Special Warnings And Precautions For Use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
MASTAFLU should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
MASTAFLU may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the results. The transient false positive reactions could be due to the IgM response by the vaccine.
4.6 Pregnancy And Lactation
Limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
MASTAFLU may be used during lactation.
4.7 Effects On Ability To Drive And Use Machines
MASTAFLU is unlikely to produce an effect on the ability to drive and use machines.
4.8 Undesirable Effects
Adverse events from clinical trials:
The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18-60 and at least 50 elderly subjects aged 60 or older. Safety evaluation is performed during the first 3 days following vaccination.
Undesirable effects reported are listed according to the following frequency:
Adverse events from clinical trials:
Common (>1/100, <1/10)
Local reactions: redness, swelling, pain, ecchymosis, induration.
Systemic reactions: fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia. These reactions usually disappear within 1-2 days without treatment.
From post-marketing surveillance additionally, the following adverse events have been reported:
Uncommon (>1/1,000, <1/100)
Generalised skin reactions including pruritus, urticaria or non-specific rash.
Rare (>1/10,000, <1/1,000)
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.
Allergic reactions, in rare cases leading to shock, have been reported.
Very rare (<1/10,000)
Vasculitis with transient renal involvement. Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
4.9 Overdose
Overdosage is unlikely to have any untoward effect.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride, magnesium chloride hexahydrate and water for injections.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
1 year.
6.4 Special Precautions For Storage
MASTAFLU should be stored at +2°C to +8°C (in a refrigerator). Do not freeze. Protect from light.
6.5 Nature And Contents Of Container
0.5 ml suspension for injection in pre-filled syringe (glass, type 1), pack of 1 or 10.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
MASTAFLU should be allowed to reach room temperature before use. Shake before use.
For administration of a 0.25 ml dose from a syringe, push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a reproducible volume of vaccine remains in the syringe, suitable for administration.
7. Marketing Authorisation Holder
Solvay Healthcare Limited
Mansbridge Road
West End
Southampton
SO18 3JD
8. Marketing Authorisation Number(S)
PL 00512/0170
9. Date Of First Authorisation/Renewal Of The Authorisation
14 June 2000/December 2002
10. Date Of Revision Of The Text
September 2006
Legal category
POM
Friday, July 27, 2012
Celontin
Generic Name: methsuximide (meth SUX i mide)
Brand Names: Celontin
What is Celontin (methsuximide)?
Methsuximide is an anti-epileptic medication, also called an anticonvulsant.
Methsuximide is used alone or in combination with other medications to treat absence seizures (also called "petit mal" seizures) in adults and children.
Methsuximide may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Celontin (methsuximide)?
Methsuximide can cause a decrease in many types of blood cells (white cells, red cells, platelets). Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, even if these symptoms first occur after you have been using the medication for several months.
Methsuximide may also cause liver damage. Call your doctor if you have symptoms such as loss of appetite, stomach pain, or jaundice (yellowing of the skin or eyes).
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.
Do not stop using methsuximide without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using methsuximide suddenly. You may need to use less and less before you stop the medication completely.
Contact your doctor if your seizures get worse or you have them more often while taking methsuximide.
Wear a medical alert tag or carry an ID card stating that you take methsuximide. Any doctor, dentist, or emergency medical care provider who treats you should know that you take seizure medication.
What should I discuss with my healthcare provider before taking Celontin (methsuximide)?
You should not use this medication if you are allergic to methsuximide or to other seizure medications.
To make sure you can safely take methsuximide, tell your doctor if you have any of these other conditions:
lupus;
liver disease;
kidney disease; or
a history of depression, mental illness, or suicidal thoughts or actions.
You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
It is not known whether methsuximide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Although methsuximide might harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking methsuximide, do not stop taking it without your doctor's advice. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of methsuximide on the baby. It is not known whether methsuximide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Celontin (methsuximide)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Methsuximide can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.
Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, including flu-like symptoms. These symptoms may first develop even after you have been using the medication for several months.
Do not stop using methsuximide without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using methsuximide suddenly. You may need to use less and less before you stop the medication completely.
Contact your doctor if your seizures get worse or you have them more often while taking methsuximide.
Wear a medical alert tag or carry an ID card stating that you take methsuximide. Any medical care provider who treats you should know that you take seizure medication.
Use methsuximide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture, heat, and light. High heat can cause a methsuximide capsule to melt.
See also: Celontin dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include vomiting, extreme drowsiness, and weak or shallow breathing.
What should I avoid while taking Celontin (methsuximide)?
Methsuximide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Drinking alcohol can increase certain drowsiness or dizziness caused by methsuximide.
Celontin (methsuximide) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a serious side effect such as:
signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), mouth sores, feeling very weak or tired;
signs of liver damage, such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
joint pain or swelling with fever, swollen glands, muscle aches, chest pain;
patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling; or
worsening of seizures.
Less serious side effects may include:
diarrhea, constipation;
stomach pain, nausea, weight loss;
dizziness, drowsiness, nervousness, confusion;
headache;
blurred vision; or
loss of balance or coordination.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Celontin (methsuximide)?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by methsuximide. Tell your doctor if you regularly use any of these medicines..
Tell your doctor about all other seizure medication you use, especially:
phenobarbital (Luminal, Solfoton); or
phenytoin (Dilantin).
This list is not complete and other drugs may interact with methsuximide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Celontin resources
- Celontin Side Effects (in more detail)
- Celontin Dosage
- Celontin Use in Pregnancy & Breastfeeding
- Drug Images
- Celontin Drug Interactions
- Celontin Support Group
- 0 Reviews for Celontin - Add your own review/rating
- Celontin MedFacts Consumer Leaflet (Wolters Kluwer)
- Celontin Prescribing Information (FDA)
- methsuximide Advanced Consumer (Micromedex) - Includes Dosage Information
- Methsuximide Professional Patient Advice (Wolters Kluwer)
Compare Celontin with other medications
- Seizures
Where can I get more information?
- Your pharmacist can provide more information about methsuximide.
See also: Celontin side effects (in more detail)
Optrex Bloodshot Eye Drops
1. Name Of The Medicinal Product
Optrex Bloodshot Eye Drops
2. Qualitative And Quantitative Composition
Actives
Hamamelis water* BPC 12.5% v/v
Naphazoline hydrochloride EP 0.01% w/v
(*Synonyms. Distilled witch hazel, Witch hazel)
3. Pharmaceutical Form
Eye drops
4. Clinical Particulars
4.1 Therapeutic Indications
For temporary relief of redness of the eye due to minor eye irritations.
4.2 Posology And Method Of Administration
For topical application to the eye.
Adults, children over 12 years and the elderly:
Gently squeeze one to two drops into the corner of each eye. No more than 4 times daily.
Children under 12 years:
Not recommended.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Persons suffering from glaucoma, serious eye diseases or who have had previous eye surgery.
4.4 Special Warnings And Precautions For Use
Not to be used by contact lens wearers whilst wearing lenses.
If you are being treated for high blood pressure, depression, heart disease, diabetes or increased thyroid activity consult your doctor before using the drops.
Discard any eye drops remaining 28 days after opening the container.
Continued use of this product may increase redness of the eye.
If you experience eye pain, changes in vision or continued redness of the eye, or if the condition worsens or persists for more than 24 hours consult a doctor.
If you have any eye disease, suffer from glaucoma or have had eye surgery, do not use this product except under the advice and supervision of a doctor.
If the solution changes colour or becomes cloudy do not use.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
May interact with other topically applied autonomic drugs used in the treatment of glaucoma. May interact with monoamine oxidase inhibitors and should not be used by patients receiving such treatment or within 14 days of ceasing therapy. May reverse the antihypertensive action of drugs used in the treatment of hypertension. There may be an increased risk of arrhythmias in patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
4.6 Pregnancy And Lactation
Although the safety of Optrex Red Eyes Eye Drops during pregnancy and lactation has not been established, it is unlikely that sufficient of the active ingredients will reach the foetus or the breast-fed infant to be harmful.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Transient irritation and stinging may occur. Following long term use a rebound secondary hyperaemia may occur.
4.9 Overdose
If applied in excessive quantities to the eye, it may give rise to irritation and stinging. Overdosage by mouth may cause nausea, headache, depression of the central nervous system with marked reduction of body temperature and symptoms of bradycardia, sweating, drowsiness and coma, particularly in children. In addition, may cause hypertension followed by rebound hypotension. Treatment of adverse effects should be symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Naphazoline is a sympathomimetic amine with pronounced alpha adrenergic activity and as a consequence has vasoconstrictor activity.
Distilled witch hazel has astringent properties.
5.2 Pharmacokinetic Properties
Although there are no specific pharmacokinetic properties for this product, systematic absorption of naphazoline may take place following topical application.
5.3 Preclinical Safety Data
There are no preclinical safety data of relevance to the consumer.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerin
Boric acid
Borax
Disodium edetate
Benzalkonium chloride
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
a) Unopened: 24 months.
b) After first opening: 28 days.
6.4 Special Precautions For Storage
Store below 25°C.
Do not freeze.
6.5 Nature And Contents Of Container
A pigmented high density/low density polythene bottle having a polythene plug and wadless high density polyethylene tamper evident cap. Pack size is 10ml.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Optrex Limited
1 Thane Road West
Nottingham
NG2 3AA
8. Marketing Authorisation Number(S)
PL 00062/0024
9. Date Of First Authorisation/Renewal Of The Authorisation
11 April 1978 / 08 July 1997
10. Date Of Revision Of The Text
15/04/2008
Thursday, July 26, 2012
Ibuleve Mousse
1. Name Of The Medicinal Product
IBULEVE™ MOUSSE
2. Qualitative And Quantitative Composition
Ibuprofen 5.0% w/w.
3. Pharmaceutical Form
Non-greasy, fragrance-free, white aqueous cutaneous foam
4. Clinical Particulars
4.1 Therapeutic Indications
For fast local relief of pain and inflammation in musculoskeletal conditions including backache, rheumatic and muscular pain, sprains, strains, lumbago and fibrositis, and neuralgia. Ibuleve Mousse is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.
4.2 Posology And Method Of Administration
Shake container before use. Hold container upright, then press nozzle to dispense the mousse into the palm of your hand. Gently massage the mousse into and around the affected areas until absorbed. The exact amount to be applied will vary, depending on the extent and severity of the condition, but it should normally be sufficient to apply 1 to 2 g (1 to 2 golf-ball sized quantities of mousse dispensed into the palm of the hand). This amount may be repeated up to 3 to 4 times daily unless otherwise directed by the doctor.
Treatment should not normally continue for more than a few weeks, unless recommended by a doctor.
The same dosage and dosage schedule applies to all age groups, although the mousse is not normally recommended for children under 12 years, unless instructed by their doctor.
4.3 Contraindications
Not to be used if allergic to any of the ingredients, or in cases of hypersensitivity to aspirin, ibuprofen or related painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis or urticaria.
Not to be used on broken or damaged skin, or where there is infection or other skin disease.
4.4 Special Warnings And Precautions For Use
This product is flammable. Do not spray near flames, burning cigarettes, electric heaters or similar objects.
Keep away from the eyes and mucous membranes.
Oral NSAID's, including ibuprofen, can sometimes be associated with renal impairment or aggravation of active peptic ulcers, and they can induce allergic bronchial reactions in susceptible asthmatic patients. Although systemic absorption of topically applied ibuprofen is much less than for oral dosage forms, these complications can still occur in rare cases. For these reasons, patients with asthma, an active peptic ulcer or a history of kidney problems, should seek medical advice before using the mousse, as should patients already taking other painkillers.
Patients should seek medical advice if symptoms worsen or persist.
For external use only.
Wash hands after use unless treating them.
Do not use excessively.
The label will include statements to the following effect:
Do not exceed the stated dose. Not recommended for children under 12 years without medical advice. For external use only. Not to be used during pregnancy or breast feeding. Do not use if you are allergic to any of the ingredients or have experienced problems with aspirin, ibuprofen or related painkillers (including when taken by mouth). If symptoms persist consult your doctor or pharmacist. Keep out of the reach of children. Patients with asthma, an active peptic ulcer or a history of kidney problems should consult their doctor before use, as should patients already taking aspirin or other painkillers.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDs may result in an increased incidence of undesirable effects.
4.6 Pregnancy And Lactation
Not to be used during pregnancy or lactation. Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased. Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast-fed infants adversely.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
The cooling effect of the mousse may result in a temporary paling of the skin.
Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be discontinued:
Hypersensitivity: hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Renal: renal impairment can occur in patients with a history of kidney problems.
Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported.
4.9 Overdose
Any overdose with a topical presentation of ibuprofen is extremely unlikely.
Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The mousse is for topical application. Ibuprofen is a phenylpropionic acid derivative with analgesic and anti-inflammatory properties. It exerts its effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis.
Because it is formulated in an aqueous mousse, the preparation also exerts a soothing and cooling effect when applied to the affected area.
5.2 Pharmacokinetic Properties
Ibuleve Mousse has been designed for external application. The formulation delivers the active ingredient through the skin rapidly and extensively, achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and the synovial fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic side-effects, other than in rare or susceptible individuals who are hypersensitive to ibuprofen.
There do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion of ibuprofen.
5.3 Preclinical Safety Data
No relevant information additional to that contained elsewhere in the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Propylene Glycol; Carbomer; Phenoxyethanol; Diethylamine; Butane 40; Purified Water.
(The ozone-friendly aerosol propellent is a blend of C2 - H5 hydrocarbons consisting primarily of propane, iso-butane and n-butane).
6.2 Incompatibilities
None known.
6.3 Shelf Life
48 months.
6.4 Special Precautions For Storage
Do not store above 25˚C. Keep upright and away from direct heat or sunlight. Do not expose pressurised container to temperatures higher than 50oC. Do not pierce or burn container, even when empty.
6.5 Nature And Contents Of Container
Aluminium pressurised container incorporating a spray valve and cap containing 75 g of product. This is supplied as an original pack (OP).
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Diomed Developments Limited
Tatmore Place, Gosmore
Hitchin, Herts SG4 7QR, UK
8. Marketing Authorisation Number(S)
00173/0168.
9. Date Of First Authorisation/Renewal Of The Authorisation
22 May 2008.
10. Date Of Revision Of The Text
October 2007.
Wednesday, July 25, 2012
Good Neighbor Tioconazole 1
Dosage Form: vaginal ointment
Amerisource Bergen Tioconazole 1 Drug Facts
Active ingredient (in each applicator)
Tioconazole 300 mg (6.5%)
Purpose
Vaginal antifungal
Uses
- treats vaginal yeast infections
Warnings
For vaginal use only
Do not use
if you have never had a vaginal yeast infection diagnosed by a doctor
Ask a doctor before use if you have
- vaginal itching and discomfort for the first time
- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- been exposed to human immunodeficiency virus (HIV) that causes AIDS
When using this product
- do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
Stop use and ask a doctor if
- symptoms do not get better after 3 days
- symptoms last more than 7 days
- you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
- adults and children 12 years and over:
- open the foil packet just before use and remove purple cap
- insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
- children under 12 years of age: ask a doctor
Other information
- this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.
- if you have questions about vaginal yeast infections, consult your doctor
- store at 20° - 25°C (68° - 77°F)
- see end flap of carton for lot number and expiration date
Inactive ingredients
butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum
Questions or comments?
1-800-719-9260
Principal Display Panel
Compare to active ingredient in 1-Day™
Tioconazole 1
Tioconazole Ointment, 6.5%
Vaginal Antifungal
Cures Most Vaginal Yeast Infections
1-Dose Treatment
Educational Brochure Enclosed
# Prefilled Applicator
Tioconazole 1 Carton
| GOOD NEIGHBOR PHARMACY TIOCONAZOLE 1 tioconazole ointment | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075915 | 02/20/2008 | |
| Labeler - Amerisource Bergen (007914906) |
More Good Neighbor Tioconazole 1 resources
- Good Neighbor Tioconazole 1 Side Effects (in more detail)
- Good Neighbor Tioconazole 1 Use in Pregnancy & Breastfeeding
- Good Neighbor Tioconazole 1 Support Group
- 7 Reviews for Good Neighbor Tioconazole - Add your own review/rating
Compare Good Neighbor Tioconazole 1 with other medications
- Vaginal Yeast Infection
Tuesday, July 24, 2012
Conjugated Estrogens (Synthetic A)
Pronunciation: CON-ju-gate-ed ESS-tro-jenz
Generic Name: Conjugated Estrogens (Synthetic A)
Brand Name: Cenestin
Conjugated Estrogens (Synthetic A) increases the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while using Conjugated Estrogens (Synthetic A). Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.
Do not use Conjugated Estrogens (Synthetic A) with or without progestins (eg, medroxyprogesterone) to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women 65 years of age or older. You and your health care provider should talk regularly about whether you still need treatment with Conjugated Estrogens (Synthetic A).
Conjugated Estrogens (Synthetic A) is used for:
Treating a variety of symptoms due to menopause (hot flashes, vaginal itching, burning, dryness). It may also be used for other conditions as determined by your doctor.
Conjugated Estrogens (Synthetic A) is a mixture of estrogen hormones. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.
Do NOT use Conjugated Estrogens (Synthetic A) if:
- you are allergic to any ingredient in Conjugated Estrogens (Synthetic A)
- you are pregnant or suspect you may be pregnant
- you have known, suspected, or a history of breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent
- you have abnormal vaginal bleeding of unknown cause
- you have impaired liver function or liver disease, or the blood disease porphyria
- you have recently (within the last year) had a stroke or heart attack
- you have blood clots or circulation disorders
Contact your doctor or health care provider right away if any of these apply to you.
Before using Conjugated Estrogens (Synthetic A):
Some medical conditions may interact with Conjugated Estrogens (Synthetic A). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to become pregnant or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have an abnormal mammogram
- if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood
- if you use tobacco, you are going to have surgery, or you will be on bed rest
- if you have a family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer
Some MEDICINES MAY INTERACT with Conjugated Estrogens (Synthetic A). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Hydantoins (eg, phenytoin) and rifampin because they may decrease Conjugated Estrogens (Synthetic A)'s effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Conjugated Estrogens (Synthetic A) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Conjugated Estrogens (Synthetic A):
Use Conjugated Estrogens (Synthetic A) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Conjugated Estrogens (Synthetic A). Talk to your pharmacist if you have questions about this information.
- Take Conjugated Estrogens (Synthetic A) by mouth with food or immediately after a meal to prevent stomach upset.
- Take Conjugated Estrogens (Synthetic A) at the same time each day.
- Discuss with your doctor stopping Conjugated Estrogens (Synthetic A) 4 to 6 weeks before surgery.
- If you miss a dose of Conjugated Estrogens (Synthetic A), take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Conjugated Estrogens (Synthetic A).
Important safety information:
- Conjugated Estrogens (Synthetic A) may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Conjugated Estrogens (Synthetic A) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Smoking while taking Conjugated Estrogens (Synthetic A) may increase your risk of blood clots (especially in women older than 35 years of age).
- Before using Conjugated Estrogens (Synthetic A), you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.
- You should have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
- Your doctor should reevaluate you every 3 to 6 months to determine whether or not you need to continue taking Conjugated Estrogens (Synthetic A).
- If you are only being treated for vaginal menopause symptoms, products applied locally such as vaginal creams, tablets, or rings should be considered before products taken by mouth or absorbed through the skin. If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.
- Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor of pharmacist for more details.
- Diabetes patients - Conjugated Estrogens (Synthetic A) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Conjugated Estrogens (Synthetic A) may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Conjugated Estrogens (Synthetic A).
- Conjugated Estrogens (Synthetic A) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Conjugated Estrogens (Synthetic A).
- Lab tests, including a lipid profile, may be performed while you use Conjugated Estrogens (Synthetic A). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Conjugated Estrogens (Synthetic A) should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- Conjugated Estrogens (Synthetic A) may affect growth in CHILDREN. They may need regular growth checks while they use Conjugated Estrogens (Synthetic A).
- PREGNANCY and BREAST-FEEDING: Do not use Conjugated Estrogens (Synthetic A) if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Conjugated Estrogens (Synthetic A) is found in breast milk. If you are or will be breast-feeding while you use Conjugated Estrogens (Synthetic A), check with your doctor. Discuss any possible risks to your baby..
Possible side effects of Conjugated Estrogens (Synthetic A):
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; dizziness; fainting; mental/mood changes; pain or tenderness in the upper abdomen; pain in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding 2 to 7 days following overdose; nausea and vomiting.
Proper storage of Conjugated Estrogens (Synthetic A):
Store Conjugated Estrogens (Synthetic A) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Conjugated Estrogens (Synthetic A) out of the reach of children and away from pets.
General information:
- If you have any questions about Conjugated Estrogens (Synthetic A), please talk with your doctor, pharmacist, or other health care provider.
- Conjugated Estrogens (Synthetic A) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Conjugated Estrogens (Synthetic A). Additionally, your doctor may have prescribed Conjugated Estrogens (Synthetic A) for a use not mentioned above. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Conjugated Estrogens (Synthetic A) resources
- Conjugated Estrogens (Synthetic A) Dosage
- Conjugated Estrogens (Synthetic A) Use in Pregnancy & Breastfeeding
- Conjugated Estrogens (Synthetic A) Drug Interactions
- Conjugated Estrogens (Synthetic A) Support Group
- 16 Reviews for Conjugated Estrogens (Synthetic A) - Add your own review/rating
Compare Conjugated Estrogens (Synthetic A) with other medications
- Abnormal Uterine Bleeding
- Atrophic Urethritis
- Atrophic Vaginitis
- Breast Cancer, Palliative
- Hypoestrogenism
- Oophorectomy
- Osteoporosis
- Postmenopausal Symptoms
- Primary Ovarian Failure
- Prostate Cancer
Sunday, July 22, 2012
Chromium Picolinate
Pronunciation: KROE-mee-uhm pi-KOE-li-nate
Generic Name: Chromium Picolinate
Brand Name: Generic only. No brands available.
Chromium Picolinate is used for:
Treating or preventing chromium deficiency.
Chromium Picolinate is a mineral. It works by increasing the blood levels of chromium.
Do NOT use Chromium Picolinate if:
- you are allergic to any ingredient in Chromium Picolinate
Contact your doctor or health care provider right away if any of these apply to you.
Before using Chromium Picolinate:
Some medical conditions may interact with Chromium Picolinate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
Some MEDICINES MAY INTERACT with Chromium Picolinate. However, no specific interactions with Chromium Picolinate are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Chromium Picolinate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Chromium Picolinate:
Use Chromium Picolinate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Chromium Picolinate with food.
- Take Chromium Picolinate with a full glass of water (8 oz/240 mL).
- If you miss taking a dose of Chromium Picolinate for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.
Ask your health care provider any questions you may have about how to use Chromium Picolinate.
Important safety information:
- Diabetes patients - Chromium Picolinate may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Chromium Picolinate during pregnancy. If you are or will be breast-feeding while you are using Chromium Picolinate, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Chromium Picolinate:
All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Chromium Picolinate side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include kidney or liver damage; loss of consciousness; seizures; upset stomach; vomiting.
Proper storage of Chromium Picolinate:
Store Chromium Picolinate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chromium Picolinate out of the reach of children and away from pets.
General information:
- If you have any questions about Chromium Picolinate, please talk with your doctor, pharmacist, or other health care provider.
- Chromium Picolinate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Chromium Picolinate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Chromium Picolinate resources
- Chromium Picolinate Side Effects (in more detail)
- Chromium Picolinate Use in Pregnancy & Breastfeeding
- Chromium Picolinate Drug Interactions
- Chromium Picolinate Support Group
- 4 Reviews for Chromium Picolinate - Add your own review/rating
- chromium picolinate Concise Consumer Information (Cerner Multum)
Compare Chromium Picolinate with other medications
- Diabetes, Type 2
- Vitamin/Mineral Supplementation and Deficiency
Friday, July 20, 2012
Lincocin
lincomycin
Dosage Form: injection, solution
Lincocin®
lincomycin injection, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincocin and other antibacterial drugs, Lincocin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Warning
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cleocin Phosphate and may range in severity from mild diarrhea to fatal colits. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
Because lincomycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
C.diffficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Lincocin Description
Lincocin Sterile Solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8 - dideoxy - 6 - (1 - methyl - trans - 4 - propyl - L - 2 - pyrolidinecarboxamido) - 1 - thio - D - erythro - α - D - galacto - octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01.
The structural formula is represented below:
Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone.
Lincocin - Clinical Pharmacology
Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum levels of 11.6 µg/mL at 60 minutes and maintains therapeutic levels for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent).
A two hour intravenous infusion of 600 mg of lincomycin achieves average peak serum levels of 15.9 µg/mL and yields therapeutic levels for 14 hours for most susceptible gram-positive organisms. Urinary excretion ranges from 4.9 to 30.3 percent (mean: 13.8 percent).
The biological half-life after intramuscular or intravenous administration is 5.4 ± 1.0 hours. The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum.
Tissue level studies indicate that bile is an important route of excretion. Significant levels have been demonstrated in the majority of body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), levels of lincomycin in the CSF appear inadequate for the treatment of meningitis.
Microbiology
Lincomycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections: (see INDICATIONS AND USAGE).
Staphylococcus aureus (penicillinase- and non-penicillinase producing strains)
Streptococcus pneumoniae
The following in vitro data are available; but their clinical significance is unknown.
Lincomycin has been shown to be active in vitro against the following microorganisms; however, the safety and efficacy of Lincocin in treating clinical infections due to these organisms have not been established in adequate and well controlled trials.
Aerobic gram-positive cocci:
Streptococcus pyogenes
Viridans group streptococci
Aerobic gram-positive bacilli:
Corynebacterium diphtheriae
Anaerobic gram-positive non-sporeforming bacilli:
Propionibacterium acnes
Anaerobic gram-positive sporeforming bacilli:
Clostridium tetani
Clostridium perfringens
This drug is not active against most strains of Enterococcus faecalis nor against Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae or other gram-negative organisms or yeasts.
Cross resistance has been demonstrated between clindamycin and lincomycin. Some cross resistance with erythromycin including a phenomenon known as dissociated cross resistance or macrolide effect has been reported.
Studies indicate that lincomycin does not share antigenicity with penicillin compounds.
Indications and Usage for Lincocin
Lincocin Sterile Solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the WARNING box, before selecting lincomycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to lincomycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Lincomycin has been demonstrated to be effective in the treatment of staphylococcal infections resistant to other antibiotics and susceptible to lincomycin. Staphylococcal strains resistant to Lincocin have been recovered; culture and susceptibility studies should be done in conjunction with therapy with Lincocin. In the case of macrolides, partial but not complete cross resistance may occur (see Microbiology). The drug may be administered concomitantly with other antimicrobial agents when indicated.
Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincocin and other antibacterial drugs, Lincocin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Contraindications
This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.
Warnings
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Other causes of colitis should also be considered. A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.
Lincocin Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants.
Usage in Meningitis — Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis.
SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN AND INTRAVENOUS CORTICOSTEROIDS SHOULD ALSO BE ADMINISTERED AS INDICATED. (See ADVERSE REACTIONS.)
Precautions
General
Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When Lincocin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Lincocin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Lincocin should be used with caution in patients with a history of asthma or significant allergies.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy.
The use of Lincocin may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with Lincocin, concomitant antimonilial treatment should be given.
The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function.
Patients with severe impairment of renal function and/or abnormal hepatic function should be dosed with caution and serum lincomycin levels monitored during high-dose therapy. (See DOSAGE AND ADMINISTRATION Section.)
Lincomycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the DOSAGE AND ADMINISTRATION Section.
Prescribing Lincocin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Information for Patients
Patients should be counseled that antibacterial drugs including Lincocin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Lincocin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Lincocin or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible
Laboratory Tests
During prolonged therapy with Lincocin, periodic liver and kidney function tests and blood counts should be performed.
Drug Interactions
Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used in caution in patients receiving such agents.
Antagonism between lincomycin and erythromycin in vitro has been demonstrated. Because of possible clinical significance, the two drugs should not be administered concurrently.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of lincomycin has not been evaluated.
Lincomycin was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, lincomycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, lincomycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.
Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of lincomycin (0.36 times the highest recommended human dose based on mg/m2).
Pregnancy
Pregnancy Category C
Teratogenic Effects
There are no studies on the teratogenic potential of lincomycin in animals or adequate and well-controlled studies of pregnant women.
Nonteratogenic Effects
Reproduction studies have been performed in rats using oral doses of lincomycin up to 1000 mg/kg (1.2 times the maximum daily human dose based on mg/m2) and have revealed no adverse effects on survival of offspring from birth to weaning.
Nursing Mothers
Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 mcg/mL. Because of the potential for serious adverse reactions in nursing infants from Lincocin, a decision should be made whether to discontinue nursing, or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Lincocin Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. Safety and effectiveness in pediatric patients below the age of one month have not been established. (See DOSAGE AND ADMINISTRATION Section.)
Adverse Reactions
The following reactions have been reported with the use of lincomycin:
Gastrointestinal
Glossitis, stomatitis, nausea, vomiting, antibiotic-associated diarrhea and colitis, and pruritus ani. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).
Hematopoietic
Neutropenia, leukopenia, agranulocytosis and thrombocytopenic purpura have been reported. There have been rare reports of aplastic anemia and pancytopenia in which Lincocin could not be ruled out as the causative agent.
Hypersensitivity Reactions
Hypersensitivity reactions such as angioneurotic edema, serum sickness and anaphylaxis have been reported. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with Lincocin. If an allergic reaction to Lincocin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Skin and Mucous Membranes
Skin rashes, urticaria and vaginitis and rare instances of exfoliative and vesiculobullous dermatitis have been reported.
Liver
Although no direct relationship of Lincocin to liver dysfunction has been established, jaundice and abnormal liver function tests (particularly elevations of serum transaminase) have been observed.
Renal
Although no direct relationship of lincomycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.
Cardiovascular
After too rapid intravenous administration, rare instances of cardiopulmonary arrest and hypotension have been reported. (See DOSAGE AND ADMINISTRATION.)
Special Senses
Tinnitus and vertigo have been reported occasionally.
Local Reactions
Patients have demonstrated excellent local tolerance to intramuscularly administered Lincocin. Reports of pain following injection have been infrequent. Intravenous administration of Lincocin in 250 to 500 mL of 5% dextrose injection or 0.9% sodium chloride injection produced no local irritation or phlebitis.
Overdosage
Serum levels of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.
Lincocin Dosage and Administration
If significant diarrhea occurs during therapy, this antibiotic should be discontinued. (See WARNING box.)
INTRAMUSCULAR
Adults
Serious infections—600 mg (2 mL) intramuscularly every 24 hours. More severe infections—600 mg (2 mL) intramuscularly every 12 hours or more often.
Pediatric patients over 1 month of age
Serious infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections—one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often.
INTRAVENOUS
Adults
The intravenous dose will be determined by the severity of the infection. For serious infections doses of 600 mg of lincomycin (2 mL of Lincocin) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations daily intravenous doses of as much as 8 grams have been given. Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 mL of appropriate solution (see PHYSICAL COMPATIBILITIES) and infused over a period of not less than one hour.
| Dose | Vol. Diluent | Time |
|---|---|---|
| 600 mg | 100 mL | 1 hr |
| 1 gram | 100 mL | 1 hr |
| 2 grams | 200 mL | 2 hr |
| 3 grams | 300 mL | 3 hr |
| 4 grams | 400 mL | 4 hr |
These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin.
Pediatric patients over 1 month of age
10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults.
NOTE: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.
SUBCONJUNCTIVAL INJECTION
0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibiotic (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens.
Patients with diminished renal function
When therapy with Lincocin is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys.
How is Lincocin Supplied
Lincocin Sterile Solution is available in the following strength and package sizes:
300 mg
2 mL Vials — NDC 0009-0555-01
10 mL Vials — NDC 0009-0555-02
Each mL of Lincocin Sterile Solution contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative.
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Animal Pharmacology
In vivo experimental animal studies demonstrated the effectiveness of Lincocin preparations (lincomycin) in protecting animals infected with Streptococcus viridans,β-hemolytic Streptococcus, Staphylococcus aureus, Diplococcus pneumoniae and Leptospira pomona. It was ineffective in Klebsiella, Pasteurella, Pseudomonas, Salmonella and Shigella infections.
Clinical Studies
Experience with 345 obstetrical patients receiving this drug revealed no ill effects related to pregnancy.
PHYSICAL COMPATIBILITIES
Physically compatible for 24 hours at room temperature unless otherwise indicated.
Infusion Solutions
5% Dextrose Injection
10% Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride Injection
10% Dextrose and 0.9% Sodium Chloride Injection
Ringer's Injection
1/6 M Sodium Lactate Injection
Travert 10%-Electrolyte No. 1
Dextran in Saline 6% w/v
Vitamins in Infusion Solutions
B-Complex
B-Complex with Ascorbic Acid
Antibiotics in Infusion Solutions
Penicillin G Sodium (Satisfactory for 4 hours)
Cephalothin
Tetracycline HCl
Cephaloridine
Colistimethate (Satisfactory for 4 hours)
Ampicillin
Methicillin
Chloramphenicol
Polymyxin B Sulfate
Physically Incompatible with:
Novobiocin
Kanamycin
IT SHOULD BE EMPHASIZED THAT THE COMPATIBLE AND INCOMPATIBLE DETERMINATIONS ARE PHYSICAL OBSERVATIONS ONLY, NOT CHEMICAL DETERMINATIONS. ADEQUATE CLINICAL EVALUATION OF THE SAFETY AND EFFICACY OF THESE COMBINATIONS HAS NOT BEEN PERFORMED.
Rx only
LAB-0138-4.0
June 2007
PRINCIPAL DISPLAY PANEL - 1-2 mL Vial Carton
NDC 0009-0555-01
1-2 mL Vial
Rx only
Lincocin®
lincomycin
injection, USP
For intramuscular or
intravenous use
300 mg/mL*
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
| Lincocin lincomycin injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA050317 | 12/29/1964 | |
| Labeler - Pharmacia and Upjohn Company (829076566) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pharmacia and Upjohn Company | 829076566 | MANUFACTURE | |
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