What Is Clindamycin Phosphate Gel Used For

What is Clindamycin Phosphate Topical Solution and how is it used?

Clindamycin Phosphate Topical Solution is a prescription medicine used to treat the symptoms of certain type of vaginal infection (Bacterial Vaginosis). Clindamycin Phosphate Topical Solution may exist used solitary or with other medications.

Clindamycin Phosphate Topical Solution belongs to a class of drugs called Antibiotics, Lincosamine.

What are the possible side effects of Clindamycin Phosphate Topical Solution?

Clindamycin Phosphate Topical Solution may cause serious side furnishings including:

new or irresolute vaginal discharge,
diarrhea,
abdominal or stomach pain,
cramping,
blood or mucus in your stool,
rash,
itching or swelling of the face, tongue or throat),
severe dizziness, and
trouble breathing

Become medical aid right away, if you accept any of the symptoms listed in a higher place.

The about common side effects of Clindamycin Phosphate Topical Solution include:

mild stomach upset,
headache,
back hurting,
constipation,
urinary tract infection, and
vaginal discomfort, itching, or discharge

Tell the physician if you lot take any side effect that bothers y'all or that does not get away.

These are not all the possible side effects of Clindamycin Phosphate Topical Solution. For more information, ask your medico or pharmacist.

Telephone call your physician for medical advice well-nigh side furnishings. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Clindamycin Phosphate Topical Solution, USP 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.

Clindamycin phosphate is a h2o soluble ester of the semi-synthetic antibiotic produced by a seven(South)- chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The solution contains isopropyl booze 50% five/five, propylene glycol, purified water and sodium hydroxide. Sodium hydroxide or hydrochloric acid may be added to adjust pH.

The structural formula is represented below:

CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION, USP 1% Structural Formula Illustration

The chemical proper noun for clindamycin phosphate is Methyl 7-chloro-6,vii,8-trideoxy-vi-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-ane- thio-L-threo-α-D-galacto-octopyranoside ii-(dihydrogen phosphate).

3 pharmacies nigh 11430 have coupons for clindamycin phosphate topical solution (Brand Names:Clindamycin Phosphate Topical Solution for 150MG)

INDICATIONS

Clindamycin Phosphate Topical Solution, USP 1% is indicated in the handling of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the doc should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS and Agin REACTIONS).

DOSAGE AND Assistants

Apply a sparse film of Clindamycin Phosphate Topical Solution twice daily to afflicted area. Keep all liquid dosage forms in containers tightly closed.

HOW SUPPLIED

Clindamycin Phosphate Topical Solution, USP one% containing clindamycin phosphate equivalent to ten mg clindamycin per milliliter is bachelor in the following sizes:

thirty mL applicator bottles - NDC 0472-0987-91
lx mL applicator bottles - NDC 0472-0987-92

Store at twenty°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from freezing.

Manufactured past: Thou&W Laboratories, Inc., 111 Coolidge Street, Due south Plainfield, NJ 07080. Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA. Revised: Sep 2016

SLIDESHOW

Peel Wellness: 15 Tips for Clear Skin See Slideshow

Side Effects & Drug Interactions

SIDE Effects

In 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of handling emergent adverse dermatologic events [run across tabular array].

Number of Patients Reporting Events

Handling Emergent Adverse Event	Solution n=553 [%)	Gel n=148(%)	Lotion n=160(%)
Burning	62 (eleven)	15 (10)	17 (xi)
Itching	36 (seven)	15 (10)	17 (eleven)
Burning/Itching	60 (11)	# (-)	# (-)
Dryness	105(19)	34 (23)	29 (18)
Erythema	86 (16)	10 (7)	22 (14)
Oiliness/OiSy Skin	eight (1)	26 (18)	12* (10)
Peeling	61 (11)	# (-)	xi (seven)

Orally and parenterally administered clindamycin has been associated with severe colitis which may terminate fatally.

Cases of diarrhea, encarmine diarrhea and colitis (including pseudomembranous colitis) accept been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (come across WARNINGS).

Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, heart pain and contact dermatitis have also been reported in association with the employ of topical formulations of clindamycin.

To report SUSPECTED Agin REACTIONS, contact G&West Laboratories , Inc. at 1-800- 922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.

WARNINGS

Orally and parenterally administered clindamycin has been associated with severe colitis which may event in patient death. Use of the topical formulation of clindamycin results in absorption of the antibody from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis ) have been reported with the use of topical and systemic clindamycin.

Studies indicate a toxin(s) produced by clostridia is 1 primary cause of antibiotic associated colitis. The colitis is normally characterized past severe persistent diarrhea and severe abdominal cramps and may exist associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

When significant diarrhea occurs, the drug should exist discontinued. Large bowel endoscopy should exist considered to establish a definitive diagnosis incases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been establish to be effective in the treatment of antibioticassociated pseudomembranous colitis produced by Clostridium difficile. The usual adult dos age is 500 milligrams to two grams of vancomycin orally per day in three to iv divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a res in and vancomycin are to be administered meantime, information technology may be advisable to divide the time of administration of each drug.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

PRECAUTIONS

General

Clindamycin Phosphate Topical Solution contains an alcohol base of operations which volition crusade burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (heart, abraded skin, mucous membranes), breast-stroke with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the oral fissure.

Clindamycin Phosphate Topical Solution should exist prescribed with circumspection in atopic individuals.

Pregnancy

Teratogenic Effects

Pregnancy Category B.

In clinical trials with significant women, the systemic administration of clindamycin during the 2d and tertiary trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the starting time trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of Clindamycin Phosphate Topical Solution. However, orally and parenterally administered clindamycin has been reported to appear in chest milk. Because of the potential for serious agin reactions in nursing infants, a conclusion should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the female parent.

Pediatric Employ

Safety and effectiveness in pediatric patients nether the historic period of 12 take not been established.

Geriatric Apply

Clinical studies for clindamycin phosphate topical solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has non identified differences in responses between the elderly and younger patients.

Overdosage & Contraindications

OVERDOSE

Topically applied Clindamycin Phosphate Topical Solution tin be captivated in sufficient amounts to produce systemic furnishings (see WARNINGS).

CONTRAINDICATIONS

Clindamycin Phosphate Topical Solution is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

CLINICAL PHARMACOLOGY

Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially agile clindamycin.

Cross resistance has been demonstrated between clindamycin and lincomycin.

Antagonism has been demonstrated between clindamycin and erythromycin.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are nowadays in the serum (0-three ng/mL) and less than 0.two% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones later on awarding of Clindamycin Phosphate Topical Solution for four weeks was 597 mcg/1000 of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Costless fat acids on the skin surface accept been decreased from approximately 14% to 2% following application of clindamycin.

PATIENT Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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You lot are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.