What happens if I overdose Clinmide?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Clinmide suppositories may be harmful if swallowed.
Proper storage of Clinmide suppositories:
Store Clinmide 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 Clinmide suppositories out of the reach of children and away from pets.
Overdose of Clinmide in details
Clinmide 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 Clinmide phosphate 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 Clinmide?
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 Clinmide 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 Clinmide topical on sunburned, windburned, dry, chapped, irritated, or broken skin.
Do not smoke while using Clinmide topical foam, or immediately after applying it. The contents of the foam canister are flammable.
Clinmide warnings
Colitis
Systemic absorption of Clinmide 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 Clinmide. If significant diarrhea occurs, Clinmide Foam should be discontinued.
Severe colitis has occurred following oral or parenteral administration of Clinmide 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.
Irritation
Clinmide Foam can cause irritation. Concomitant topical acne thereapy 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, Clinmide should be discontinued.
Avoid contact of Clinmide Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water.
Clinmide Foam should be prescribed with caution in atopic individuals.
What should I discuss with my healthcare provider before taking Clinmide?
Some medical conditions may interact with Clinmide suspension. 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
- if you have diarrhea, or a history of liver problems or stomach or bowel problems (eg, colitis)
- if you have been very ill
Some MEDICINES MAY INTERACT with Clinmide suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because the risk of their side effects may be increased by Clinmide suspension
- Erythromycin because it may decrease Clinmide suspension's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Clinmide suspension 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.
Clinmide precautions
Colitis
Systemic absorption of Clinmide 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 Clinmide. If significant diarrhea occurs, Clinmide Foam should be discontinued.
Severe colitis has occurred following oral or parenteral administration of Clinmide 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.
Irritation
Clinmide 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, Clinmide should be discontinued.
Avoid contact of Clinmide Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water.
Clinmide 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 Clinmide Foam.
- Patients should use enough Clinmide Foam to cover the face and to apply once daily.
- Patients should dispense Clinmide Foam directly into the cap or onto a cool surface.
- Patients should wash their hands after applying Clinmide Foam.
Skin Irritation
Clinmide 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.
Colitis
In the event a patient treated with Clinmide Foam experiences severe diarrhea or gastrointestinal discomfort, Clinmide Foam should be discontinued and a physician should be contacted.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenicity of a 1.2% Clinmide phosphate gel similar to Clinmide 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 Clinmide phosphate from 5 milliliters of Clinmide 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% Clinmide phosphate gel similar to Clinmide 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 Clinmide hydrochloride and Clinmide palmitate hydrochloride have revealed no evidence of impaired fertility.
Use In Specific Populations
Pregnancy
Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with Clinmide Foam. Clinmide 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 Clinmide phosphate, Clinmide hydrochloride and Clinmide 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 Clinmide phosphate 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 Clinmide phosphate from Clinmide Foam based on a mg/m² comparison.
Nursing Mothers
It is not known whether Clinmide is excreted in human milk following use of Clinmide Foam. However, orally and parenterally administered Clinmide 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 Clinmide Foam is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
Pediatric Use
Safety and effectiveness of Clinmide Foam in children under the age of 12 have not been studied.
Geriatric Use
The clinical study with Clinmide 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 Clinmide?
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.
References
- DailyMed. "ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "nicotinamide". http://www.drugbank.ca/drugs/DB02701 (accessed September 17, 2018).
- DrugBank. "clindamycin". http://www.drugbank.ca/drugs/DB01190 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
