Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Clinott-P suppositories may be harmful if swallowed.
Proper storage of Clinott-P suppositories:
Store Clinott-P suppositories at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly closed container away from heat, moisture, and light. Avoid temperatures above 86 degrees F (30 degrees C) and high humidity. Do not store in the bathroom. Keep Clinott-P suppositories out of the reach of children and away from pets.
Overdose of Clinott-P in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
Clinott-P is intended for topical use only. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), rinse affected area with copious amounts of cool water.
Topically applied Clinott-P can be absorbed in sufficient amounts to produce systemic effects.
In the event of overdosage, general symptomatic and supportive measures are indicated as required.
What should I avoid while taking Clinott-P?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Clinott-P topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Do not use other medicated skin products unless your doctor has told you to. Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.
Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use Clinott-P topical on sunburned, windburned, dry, chapped, irritated, or broken skin.
Do not smoke while using Clinott-P topical foam, or immediately after applying it. The contents of the foam canister are flammable.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Clinott-P should be prescribed with caution in atopic individuals.
Cross resistance has been demonstrated between Clinott-P and lincomycin.
Do not engage in vaginal intercourse or use other vaginal products (such as tampons or douches)
during treatment with (Clinott-P vaginal cream).This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as
condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours
following treatment with this medicine is not recommended. In menstruating patients, treatment should be delayed until menstruation is completed.
Use in pregnancy:
Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of
Clinott-P ranging from 20 to 600 mg/kg/day and have revealed no evidence of impaired
fertility or harm to the fetus due to Clinott-P. In one mouse strain, cleft palates were observed
in treated fetuses; this response was not produced in other mouse strains or in other species, and
therefore may be a strain specific effect.has been studied in pregnant women during the second trimester.
In women treated for seven days, abnormal labor was reported in 1.1% of patients who received
the cream compared with 0% of women treated for three days and 0.5% of
women who received placebo for 7 days.
There are however, no adequate and well-controlled studies in pregnant women during their first
trimester, and because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed. Nursing Mothers:
It is not known if Clinott-P is excreted in breast milk following the use of vaginallyadministered
Clinott-P. However, orally and parenterally-administered Clinott-P
have been reported to appear in breast milk. Therefore, a full assessment of benefit-risk should be
made when consideration is given to using the CREAM in a nursing mother.
Approximately 4 mg of an administered dose of 100 mg Clinott-P (as Clinott-P)
is systemically absorbed following vaginal administration to the mother.
Safety and efficacy in pediatric patients have not been established.
What should I discuss with my healthcare provider before taking Clinott-P?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Clinott-P, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to Clinott-P or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on Clinott-P have been done only in adult patients, and there is no specific information comparing use of Clinott-P in children up to 12 years of age with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of Clinott-P in the elderly with use in other age groups, Clinott-P is not expected to cause different side effects or problems in older people than it does in younger adults.
Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Clinott-P, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Clinott-P with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using Clinott-P with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using Clinott-P with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Clinott-P. Make sure you tell your doctor if you have any other medical problems, especially:
History of stomach or intestinal disease (especially colitis, including colitis caused by antibiotics, or enteritis)—These conditions may increase the chance of side effects that affect the stomach and intestines
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Systemic absorption of Clinott-P has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical Clinott-P. If significant diarrhea occurs, Clinott-P Foam should be discontinued.
Severe colitis has occurred following oral or parenteral administration of Clinott-P with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
Clinott-P Foam can cause irritation. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritation or dermatitis occurs, Clinott-P should be discontinued.
Avoid contact of Clinott-P Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water.
Clinott-P Foam should be prescribed with caution in atopic individuals.
Patient Counseling Information
Instructions for Use
Patients should be advised to wash their skin with mild soap and allow it to dry before applying Clinott-P Foam.
Patients should use enough Clinott-P Foam to cover the face and to apply once daily.
Patients should dispense Clinott-P Foam directly into the cap or onto a cool surface.
Patients should wash their hands after applying Clinott-P Foam.
Clinott-P Foam may cause irritation such as erythema, scaling, itching, burning, or stinging. Patients should be advised to discontinue use if excessive irritancy or dermatitis occur.
In the event a patient treated with Clinott-P Foam experiences severe diarrhea or gastrointestinal discomfort, Clinott-P Foam should be discontinued and a physician should be contacted.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenicity of a 1.2% Clinott-P gel similar to Clinott-P Foam was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of Clinott-P from 5 milliliters of Clinott-P Foam, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.
A 1.2% Clinott-P gel similar to Clinott-P Foam caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight.
Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.
Reproduction studies in rats using oral doses of Clinott-P hydrochloride and Clinott-P palmitate hydrochloride have revealed no evidence of impaired fertility.
Use In Specific Populations
Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with Clinott-P Foam. Clinott-P Foam should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus.
Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of Clinott-P, Clinott-P hydrochloride and Clinott-P palmitate hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a Clinott-P dose of 432 mg/kg. For a rat, this dose is 84 fold higher, and for a mouse 42 fold higher, than the anticipated human dose of Clinott-P from Clinott-P Foam based on a mg/m² comparison.
It is not known whether Clinott-P is excreted in human milk following use of Clinott-P Foam. However, orally and parenterally administered Clinott-P has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, 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.
If used during lactation and Clinott-P Foam is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
Safety and effectiveness of Clinott-P Foam in children under the age of 12 have not been studied.
The clinical study with Clinott-P Foam did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.
What happens if I miss a dose of Clinott-P?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.