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Lindan

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Lindan uses


1 INDICATIONS & USAGE

Lindan phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Lindan phosphate and tretinoin gel 1.2% / 0.025% is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. (1)

2 DOSAGE & ADMINISTRATION

At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. Lindan phosphate and tretinoin gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes.

Lindan phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS & STRENGTHS

Lindan phosphate and tretinoin gel, a combination of a lincosamide antibiotic and a retinoid, contains Lindan phosphate, USP 1.2% and tretinoin, USP 0.025%, formulated as a topical gel. Each gram of Lindan phosphate and tretinoin gel contains, as dispensed, 10 mg (1%) Lindan as phosphate, USP, and 0.25 mg (0.025%) tretinoin, USP in an aqueous based gel. Lindan phosphate and tretinoin gel is available in 30 gram and 60 gram tubes.

Topical gel: Lindan phosphate, USP 1.2% and tretinoin, USP 0.025% gel in 30 and 60 gram tubes. (3)

4 CONTRAINDICATIONS

Lindan phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.

Lindan phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic–associated colitis. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Colitis

Systemic absorption of Lindan 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 Lindan. When significant diarrhea occurs, Lindan phosphate and tretinoin gel should be discontinued.

Severe colitis has occurred following oral or parenteral administration of Lindan 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.

5.2 Ultraviolet Light and Environmental Exposure

Exposure to sunlight, including sunlamps, should be avoided during the use of Lindan phosphate and tretinoin gel, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Daily use of sunscreen products and protective apparel (e.g., a hat) are recommended. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with Lindan phosphate and tretinoin gel.

6 ADVERSE REACTIONS

Observed local adverse reactions in patients treated with Lindan phosphate and tretinoin gel were skin erythema, scaling, itching, burning, and stinging. Other most commonly reported adverse events were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use for approximating rates.

The safety data presented in Table 1 (below) reflects exposure to Lindan phosphate and tretinoin gel in 1,853 patients with acne vulgaris. Patients were 12 years and older and were treated once daily for 12 weeks. Adverse reactions that were reported in ≥ 1% of patients treated with Lindan phosphate and tretinoin gel were compared to adverse reactions in patients treated with Lindan phosphate 1.2% in vehicle gel, tretinoin 0.025% in vehicle gel, and the vehicle gel alone:

Lindan
Phosphate and
Tretinoin Gel Lindan Tretinoin Vehicle
N=1853 N=1428 N=846 N=423
N (%) N (%) N (%) N (%)
Note: Formulations used in all treatment arms were in the Lindan phosphate and tretinoin vehicle gel.
PATIENTS WITH AT LEAST ONE AR 497 (27) 342 (24) 225 (27) 91 (22)
Nasopharyngitis 65 (4) 64 (5) 16 (2) 5 (1)
Pharyngolaryngeal pain 29 (2) 18 (1) 5 (1) 7 (2)
Dry skin 23 (1) 7 (1) 3 (<1) 0 (0)
Cough 19 (1) 21 (2) 9 (1) 2 (1)
Sinusitis 19 (1) 19 (1) 15 (2) 4 (1)

Cutaneous safety and tolerance evaluations were conducted at each study visit in all of the clinical trials by assessment of erythema, scaling, itching, burning, and stinging:

Local Reaction Baseline End of Treatment
N=1835 N=1614
N (%) N (%)
Erythema 636 (35) 416 (26)
Scaling 237 (13) 280 (17)
Itching 189 (10) 70 (4)
Burning 38 (2) 56 (4)
Stinging 33 (2) 27 (2)

At each study visit, application site reactions on a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe), and the mean scores were calculated for each of the local skin reactions. In Studies 1 and 2, 1277 subjects enrolled with moderate to severe acne, 854 subjects treated with Lindan phosphate and tretinoin gel and 423 treated with vehicle. Analysis over the twelve week period demonstrated that cutaneous irritation scores for erythema, scaling, itching, burning, and stinging peaked at two weeks of therapy, and were slightly higher for the Lindan phosphate and tretinoin-treated group, decreasing thereafter.

One open-label 12-month safety study for Lindan phosphate and tretinoin gel showed a similar adverse reaction profile as seen in the 12-week studies. Eighteen out of 442 subjects (4%) reported gastrointestinal symptoms.

7 DRUG INTERACTIONS

7.1 Concomitant Topical Medication

Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution. When used with Lindan phosphate and tretinoin gel, there may be increased skin irritation.

7.2 Erythromycin

Lindan phosphate and tretinoin gel should not be used in combination with erythromycin-containing products due to its Lindan component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

7.3 Neuromuscular Blocking Agents

Lindan has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Lindan phosphate and tretinoin gel should be used with caution in patients receiving such agents.

8 USE IN SPECIFIC POPULATIONS

8.1 PREGNANCY

Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Lindan phosphate and tretinoin gel. Lindan phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lindan phosphate and tretinoin gel was tested for maternal and developmental toxicity in New Zealand White Rabbits with topical doses of 60, 180 and 600 mg/kg/day. Lindan phosphate and tretinoin gel at 600 mg/kg/day was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity following dermal administration of Lindan phosphate and tretinoin gel for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. For purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of Lindan phosphate and tretinoin gel applied daily to a 60 kg person.

Lindan

Teratology (Segment II) studies using Lindan were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of Lindan in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of Lindan up to 180 mg/kg/day (175 and 88 times the amount of Lindan in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity.

Tretinoin

In oral Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison).

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. Although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison.

8.3 NURSING MOTHERS

It is not known whether Lindan is excreted in human milk following use of Lindan phosphate and tretinoin gel. However, orally and parenterally administered Lindan 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. It is not known whether tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lindan phosphate and tretinoin gel is administered to a nursing woman.

8.4 PEDIATRIC USE

Safety and effectiveness of Lindan phosphate and tretinoin gel in pediatric patients under the age of 12 have not been established.

Clinical trials of Lindan phosphate and tretinoin gel included patients 12 to 17 years of age.

8.5 GERIATRIC USE

Clinical studies of Lindan phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

11 DESCRIPTION

Lindan phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Lindan phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The chemical name for Lindan phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for Lindan phosphate, USP is represented below:

Lindan phosphate, USP:

Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97

The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all-trans form). The structural formula for tretinoin, USP is represented below:

Tretinoin, USP:

Molecular Formula: C20H28O2 Molecular Weight: 300.44

Lindan phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum.

12f9b5a2-figure-01 12f9b5a2-figure-02

12 CLINICAL PHARMACOLOGY

12.1 MECHANISMS OF ACTION

Lindan

.

Tretinoin

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

12.3 PHARMACOKINETICS

In an open-label, multiple-dose study treating 12 subjects with moderate to severe acne, the percutaneous absorption of tretinoin following 14 consecutive daily applications of approximately 4 g of Lindan phosphate and tretinoin gel was minimal. Quantifiable tretinoin plasma concentrations ranged from 1.0 to 1.6 ng/mL, with unquantifiable plasma concentrations in 50% to 92% of subjects at any given timepoint following administration. The plasma concentrations of the key tretinoin metabolites, 13- cis -retinoic acid and 4-oxo-13-cis-retinoic acid, ranged from 1.0 to 1.4 ng/mL and from 1.6 to 6.5 ng/mL, respectively. Plasma concentrations for Lindan generally did not exceed 3.5 ng/mL, with the exception of one subject whose plasma concentration reached 13.1 ng/mL.

12.4 Microbiology

Lindan binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis. Lindan has been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with Lindan phosphate and tretinoin gel. P acnes resistance to Lindan has been documented. Resistance to Lindan is often associated with resistance to erythromycin.

13 NONCLINICAL TOXICOLOGY

13.1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenicity, mutagenicity and impairment of fertility testing of Lindan phosphate and tretinoin gel have not been performed in any species.

Lindan

The carcinogenicity of a 1% Lindan phosphate gel similar to Lindan phosphate and tretinoin gel was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 13 and 72 times higher than the human dose of Lindan phosphate from Lindan phosphate and tretinoin gel, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals. For purposes of comparisons of the animal exposure to human exposure, the recommended human topical clinical dose is defined as 1 g of Lindan phosphate and tretinoin gel applied daily to a 60 kg person.

Fertility (Segment 1) studies in rats treated orally with up to 300 mg/kg/day of Lindan (approximately 290 times the amount of Lindan delivered from the recommended clinical dose for Lindan phosphate and tretinoin gel, based on a body surface area comparison) revealed no effects on fertility or mating ability.

Tretinoin

In two independent studies with long-term topical application of tretinoin in mice, carcinogenicity was not observed. In both studies, tretinoin was administered topically (0.025% or 0.1%) three times per week for up to two years. No carcinogenicity was observed with maximum effects of dermal amyloidosis in the basal layer of the skin.

Tretinoin has been shown to enhance photoco-carcinogenicity in properly performed specific studies, employing concurrent or intercurrent exposure to the drug and UV radiation. The contribution of Lindan to that effect is unknown. Although the significance of these studies to humans is not clear, patients should minimize exposure to sun.

The genotoxic potential of tretinoin was evaluated in an in vitro Ames Salmonella reversion test and an in vitro chromosomal aberration assay in Chinese hamster ovary cells. Both tests were negative.

In oral Segment 1 studies in rats treated with tretinoin, the no-observed-effect-level was 2 mg/kg/day (~78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison).

14 CLINICAL STUDIES

The safety and efficacy of once daily use of Lindan phosphate and tretinoin gel for treatment of acne vulgaris were assessed in three 12-week prospective, multi-center, randomized, blinded studies in patients 12 years and older. Studies 1 and 2 were of identical design, and compared Lindan phosphate and tretinoin gel to Lindan in the vehicle gel, tretinoin in the vehicle gel, and the vehicle gel alone. Patients with mild, moderate, or severe acne were enrolled in the studies. The co-primary efficacy variables were:

(1) Mean percent change from baseline at Week 12 in


(2) Percent of subjects who cleared or almost cleared at Week 12 as judged by an Evaluator’s Global Severity (EGS) score.

The EGS scoring scale used in all of the clinical trials for Lindan phosphate and tretinoin gel is as follows:

Grade Description
Clear Normal, clear skin with no evidence of acne vulgaris
Almost Clear Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
Mild Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions)
Moderate Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one small nodulo-cystic lesion
Severe Inflammatory lesions are more apparent many comedones and papules/pustules, there may or may not be a few nodulocystic lesions
Very Severe Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions

In Study 1, a total of 1,252 patients were enrolled, and in Study 2, a total of 1,288 patients were enrolled. The combined results are presented in Table 3.

Lindan
Phosphate and Lindan Tretinoin Vehicle
Tretinoin Gel
N=845 N=426 N=846 N=423
* Success was defined as cleared or almost cleared at Week 12
Evaluator’s Global Severity: N (%)
Patients achieving success* 180 (21%) 70 (16%) 122 (14%) 34 (8%)
Inflammatory Lesion Count (% reduction from baseline)
Mean 48% 42% 39% 26%
Non-inflammatory Lesion Count (% reduction from baseline)
Mean 36% 27% 31% 16%
Total Lesion Count (% reduction from baseline)
Mean 41% 34% 34% 20%

In Study 3, Lindan phosphate and tretinoin gel was compared to Lindan gel in a total of 2,010 patients with moderate or severe acne vulgaris. As with Studies 1 and 2, the co-primary endpoints were mean percent reduction in lesion counts (inflammatory, non-inflammatory and total) and the Evaluator’s Global Severity score. In Study 3, success on the EGS score was assessed by the percentage of subjects who had at least 2 grades of improvement from Baseline to Week 12.

Lindan Phosphate and
Tretinoin Gel Lindan
N = 1008 N = 1002
* Success was defined as at least a 2-grade improvement at Week 12 from baseline.
Evaluator’s Global Severity: N (%)
Patients achieving success* 415 (41%) 345 (34%)
Inflammatory Lesion Count (% reduction from baseline)
Mean 61% 55%
Non-inflammatory Lesion Count (% reduction from baseline)
Mean 50% 41%
Total Lesion Count (% reduction from baseline)
Mean 54% 47%

16 HOW SUPPLIED/STORAGE AND HANDLING

Lindan phosphate and tretinoin gel 1.2% / 0.025% is supplied as follows:

30 gram tube NDC 0472-1790-30

60 gram tube NDC 0472-1790-60

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). Protect from light. Protect from freezing. Keep away from heat.

Keep tube tightly closed.

Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

17.1 Instructions for Use

17.2 Skin Irritation

Lindan phosphate and tretinoin gel may cause irritation such as erythema, scaling, itching, burning, or stinging.

17.3 Colitis

In the event a patient treated with Lindan phosphate and tretinoin gel experiences severe diarrhea or gastrointestinal discomfort, Lindan phosphate and tretinoin gel should be discontinued and a physician should be contacted.

Manufactured by:

G&W laboratories, Inc.

111 Coolidge Street

South Plainfield, NJ 07080 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised – September 2015

I600-6210/11 GW 7047

17.4 FDA-Approved Patient Labeling

PATIENT INFORMATION

Lindan Phosphate and Tretinoin (klin-da-MYE-sin FOS-fate and TRET-i-noyn)

Gel 1.2% / 0.025%

IMPORTANT: Not for mouth, eye, or vaginal use.

Read the Patient Information that comes with Lindan phosphate and tretinoin gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your acne or treatment.

What is Lindan phosphate and tretinoin gel?

Lindan phosphate and tretinoin gel is an antibiotic and retinoid combination medicine used for the skin treatment of acne in patients 12 years and older.

Who should not use Lindan phosphate and tretinoin gel?

Do not use Lindan phosphate and tretinoin gel if you:


Tell your doctor:


How should I use Lindan phosphate and tretinoin gel?

Use Lindan phosphate and tretinoin gel exactly as prescribed. It may take some time for you to see improvement of your acne with Lindan phosphate and tretinoin gel. Your doctor will tell you how long to use Lindan phosphate and tretinoin gel.

At bedtime:


In the morning:


Avoid:


If your face becomes sunburned, stop Lindan phosphate and tretinoin gel until your skin has healed.

What are possible side effects with Lindan phosphate and tretinoin gel?


Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with Lindan phosphate and tretinoin gel. Ask your doctor or pharmacist for more information.

How should I store Lindan phosphate and tretinoin gel?


General information about Lindan phosphate and tretinoin gel

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use Lindan phosphate and tretinoin gel for a condition for which it was not prescribed. Do not give Lindan phosphate and tretinoin gel to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Lindan phosphate and tretinoin gel. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Lindan phosphate and tretinoin gel that is written for healthcare professionals.

If you have questions about Lindan phosphate and tretinoin gel you can also call Actavis at 1-800-432-8534.

What are the ingredients in Lindan phosphate and tretinoin gel?

Active Ingredients: Lindan phosphate, USP 1.2% and tretinoin, USP 0.025%

Inactive Ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum.

Manufactured by:

G&W laboratories, Inc.

111 Coolidge Street

South Plainfield, NJ 07080 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised – September 2015

I600-6210/11 GW 7047

Lindan pharmaceutical active ingredients containing related brand and generic drugs:


Lindan available forms, composition, doses:


Lindan destination | category:


Lindan Anatomical Therapeutic Chemical codes:


Lindan pharmaceutical companies:


References

  1. Dailymed."ZYDACLIN (CLINDAMYCIN) SOLUTION/ DROPS [MWI ]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "clindamycin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "clindamycin". http://www.drugbank.ca/drugs/DB0119... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lindan?

Depending on the reaction of the Lindan after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lindan not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Lindan addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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