Acitretin (Acitretin)

Trade Name : Acitretin

Impax Generics

CAPSULE

Strength 22.5 mg/1

ACITRETIN Retinoid [EPC],Retinoids [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acitretin (Acitretin) which is also known as Acitretin and Manufactured by Impax Generics. It is available in strength of 22.5 mg/1 per ml. Read more

Acitretin (Acitretin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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u00a0n
Rx only

Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISONn- ), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected.
Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients n- of childbearing potential n- either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification.
Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. These doses are approximately 0.2, 0.3, andu00a0 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m comparison.
Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae. n- Acitretin should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity.
Because of the teratogenicity of n- acitretin, a program called the Education and Pregnancy Prevention for Acitretin (EPPA) Program, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. The EPPAprogram requirements are described below n- and program materials are available at or may be requested by calling 1-877-994-6729n- (see alsou00a0PRECAUTIONSu00a0section).
Arrayn- Important Information for Women of Childbearing Potential:
Acitretin should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
Females of reproductive potential must not be given a prescription for acitretin until pregnancy is excluded. Acitretin is contraindicated in females of reproductive potential n
u2022 Must have had 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU per mL before receiving the initial prescription for acitretin. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue therapy with acitretin. The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of therapy with acitretin. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception [birth control] simultaneously).u00a0 n- If the second pregnancy test is negative, initiation of treatment with acitretin should begin within 7 days of the specimen collection.u00a0 Acitretin should be limited to a monthly supply.
u2022 Must have a pregnancy test n- wn- ith a sensitivity of at least 25 mIU per mLu00a0u00a0 n- repeated every month during treatment with acitretin. The patient must have a negative result from a urine or serum pregnancy test before receiving a prescription for acitretin. To encourage compliance with this recommendation, a n- mn- onthlyn- supply of the drug should be prescribed. For at least 3 years after discontinuing therapy with acitretin, a pregnancy test must be repeated every 3 months.
u2022 Must have selected and have committed to use 2 effective forms of contraception (birth control) simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy or is clearly postmenopausal.
Arrayn- u2022
Effective forms of contraception include both primary and secondary forms of contraception. Primary forms of contraception include: tubal ligation, partneru2019s vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical hormonal birth control products. Secondary forms of contraception include condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a spermicide)n- , and vaginal sponges (contains spermicide).
Any birth control method can fail. Therefore, it is critically important that women of childbearing potential use 2 effective forms of contraception (birth control) simultaneously. It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin preparations. Microdosed u201cminipillu201d progestin preparations are not recommended for use with acitretin. n n- Arrayn- Array
Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. Johnu2019s wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. Johnu2019s wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. Johnu2019s wort (see PRECAUTIONS).
u2022 Must have signed a Patient Agreement/Informed Consent for Female Patients that contains warnings about the risk of potential birth defects if the fetus is exposed to acitretin, about contraceptive failure, about the fact that they must not ingest beverages or products containing ethanol while taking acitretin and for 2 months after n- tn- ren- atn- mn- en- nn- t with n- acitretin has been discontinued, and about preventing pregnancy while taking acitretin and for at least 3 years after discontinuing acitretin.
If pregnancy does occur during therapy with n- acitretin or at any time for at least 3 years following discontinuation of acitretin, the prescriber and patient should discuss the possible effects on the pregnancy. The available information is as follows:
Acitretin, the active metabolite of etretinate, is teratogenic and is contraindicated during pregnancy. The risk of severe fetal malformations is well established when systemic retinoids are taken during pregnancy. Pregnancy must also be prevented after stopping acitretin therapy, while the drug is being eliminated to below a threshold blood concentration that would be associated with an increased incidence of birth defects. Because this threshold has not been established for acitretin in humans and because elimination rates vary among patients, the duration of posttherapy contraception to achieve adequate elimination cannot be calculated precisely. It is strongly recommended that contraception be continued for at least 3 years after stopping treatment with acitretin, based on the following considerations:
u2022 n- In the absence of transesterification to form etretinate, greater than 98% of the acitretin would be eliminated within 2 months, assuming a mean elimination half-life of 49 hours.
u2022n- In cases where etretinate is formed, as has been demonstrated with concomitant administration of acitretin and ethanol,
u00a0u00a0u00a0u00a0 u0e50 n
u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n- mean elimination half-life of 120 days.
u00a0u00a0u00a0u00a0 u0e50 n
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0the longest demonstrated elimination half-life of 168 days.
However, etretinate was found in plasma and subcutaneous fat in one patient reported to have had sporadic alcohol intake, 52 months after she stopped acitretin therapy.n
u2022u00a0u00a0Severe birth defects have been reported where conception occurred during the time interval when the patient was being treated with acitretin and/or etretinate. In addition, severe birth defects have also been reported when conception occurred after the mother completed therapy. These cases have been reported both prospectively (before the outcome was known) and retrospectively (after the outcome was known). The events below are listed without distinction as to whether the reported birth defects are consistent with retinoid-induced embryopathy or not.
Arrayn- u2022
Arrayn- u2022
Arrayn- (etretinate) must continue to follow the contraceptive recommendations for TEGISONn- . TEGISONn- is no longer marketed in the US; for information, callu00a0Impax Laboratories, Inc. at 1-877-994-6279.
u2022 n- Patients should not donate blood during and for at least 3 years following the completion of therapy with n- acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.
Arrayn- Array
Patients should not donate blood during and for at least 3 years following therapy with n- acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.
u2022 u00a0 Samples of seminal fluid from 3 male patients treated with acitretin and 6 male patients treated with etretinate have been assayed for the presenceu00a0 of acitretin. The maximum concentration of acitretin observed in the seminal fluid of these men was 12.5 ng per mL. Assuming an ejaculate volume of 10 mL, the amount of drug transferred in semen would be 125 ng, which is 1/200,000 of a single 25 mg capsule. Thus, although it appears that residual acitretin in seminal fluid poses little, if any, risk to a fetus while a male patient is taking the drug or after it is discontinued, the no-effect limit for teratogenicity is unknown and there is no registry for birth defects associated with acitretin. The available data are as follows:
There have been 25 cases of reported conception when the male partner was taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome).
u00a0 With malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck, hypoplasia of lungs bilateral, pulmonary atresia, VSD with overriding truncus arteriosus).
Arrayn- AN ACITRETIN MEDICATION GUIDE MUST BE GIVEN TO THE PATIENT EACH TIME ACITRETIN IS DISPENSED, AS REQUIRED BY LAW.

Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is:
Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black).
Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only).

The mechanism of action of acitretin is unknown.
Pharmacokinetics:
Arrayn- Absorption:
Oral absorption of acitretin is optimal when given with food. For this reason, acitretin was given with food in all of the following trials. After administration of a single 50 mg oral dose of acitretin to 18 healthy subjects, maximum plasma concentrations ranged from 196 to 728 ng per mL (mean: 416 ng per mL) and were achieved in 2 to 5 hours (mean: 2.7 hours). The oral absorption of acitretin is linear and proportional with increasing doses from 25 to 100 mg. Approximately 72% (range: 47% to 109%) of the administered dose was absorbed after a single 50 mg dose of acitretin was given to 12 healthy subjects.
Arrayn- Distribution:
Acitretin is more than 99.9% bound to plasma proteins, primarily albumin.
Arrayn- Array
Following oral absorption, acitretin undergoes extensive metabolism and interconversion by simple isomerization to its 13-cis form (cis-acitretin). The formation of cis-acitretin relative to parent compound is not altered by dose or fed/fast conditions of oral administration of acitretin. Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted. Following multiple-dose administration of acitretin, steady-state concentrations of acitretin and cis-acitretin in plasma are achieved within approximately 3 weeks.
Arrayn- Elimination:
The chain-shortened metabolites and conjugates of acitretin and cis-acitretin are ultimately excreted in the feces (34% to 54%) and urine (16% to 53%). The terminal elimination half-life of acitretin following multiple-dose administration is 49 hours (range: 33 to 96 hours), and that of cis-acitretin under the same conditions is 63 hours (range: 28 to 157 hours). The accumulation ratio of the parent compound is 1.2; that of cis-acitretin is 6.6.
Arrayn- Special Populations:
Arrayn- Psoriasis:
In an 8-week trial of acitretin pharmacokinetics in subjects with psoriasis, mean steady-state trough concentrations of acitretin increased in a dose-proportional manner with dosages ranging from 10 to 50 mg daily. Acitretin plasma concentrations were nonmeasurable (<4 ng per mL) in all subjects 3 weeks after cessation of therapy.
Arrayn- Elderly:
In a multiple-dose trial in healthy young (n=6) and elderly (n=8) subjects, a 2-fold increase in acitretin plasma concentrations were seen in elderly subjects, although the elimination half-life did not change.
Arrayn- Renal Failure:
Plasma concentrations of acitretin were significantly (59.3%) lower in subjects with end-stage renal failure (n=6) when compared with age-matched controls, following single 50 mg oral doses. Acitretin was not removed by hemodialysis in these subjects.u00a0
Arrayn- Arrayn- Array
In studies of pharmacokinetic drug interactions, no interaction was seen between acitretin and cimetidine, digoxin, phenprocoumon, or glyburide.
Arrayn- Ethanol:
Clinical evidence has shown that etretinate (a retinoid with a much longer half-life, see below) can be formed with concurrent ingestion of acitretin and ethanol. In a 2-way crossover trial, all 10 subjects formed etretinate with concurrent ingestion of a single 100 mg oral dose of acitretin during a 3-hour period of ethanol ingestion (totalu00a0ethanol, approximately 1.4 g per kg body weight). A mean peak etretinate concentration of 59 ng per mL (range: 22 to 105 ng per mL) was observed, and extrapolation of AUC values indicated that the formation of etretinate in this trial was comparable to a single 5 mg oral dose of etretinate. There was no detectable formation of etretinate when a single 100 mg oral dose of acitretin was administered without concurrent ethanol ingestion, although the formation of etretinate without concurrent ethanol ingestion cannot be excluded (see boxed CONTRAINDICATIONS AND WARNINGS). Of 93 evaluable psoriatic subjects on acitretin therapy in several foreign trials (10 to 80 mg per day), 16% had measurable etretinate levels (>5 ng per mL).
Etretinate has a much longer elimination half-life compared with that of acitretin. In one trial the apparent mean terminal half-life after 6 months of therapy was approximately 120 days (range: 84 to 168 days). In another trial of 47 subjects u00a0treated chronically with etretinate, 5 had detectable serum drug levels (in the range of 0.5 to 12 ng per mL) 2.1 to 2.9 years after therapy was discontinued. The long half-life appears to be due to storage of etretinate in adipose tissue.
Arrayn- Progestin-only Contraceptives:
It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin preparations.Microdosed u201cminipillu201d progestin preparations are recommended for use with acitretin. n n n

In 2 double-blind, placebo-controlled trials, acitretin was administered once daily to subjects with severe psoriasis (e.g., covering at least 10% to 20% of the body surface area). At 8 weeks (see Table 1) subjects treated in Trial A with 50 mg of u00a0acitretin per day showed significant improvements ( u2264 0.05) relative to baseline and to placebo in the physicianu2019s global evaluation and in the mean ratings of severity of psoriasis (scaling, thickness, and erythema). In Trial B, differences from baseline and from placebo were statistically significant ( u2264 0.05) for all variables at both the 25 mg and 50 mg doses; it should be noted for Trial B that no statistical adjustment for multiplicity was carried out.
Table 1. Summary of the Efficacy Results of the 8-Week Double-Blind Phase of n- Trialsn- A and B of Acitretin
P
A subset of 141 subjects from both pivotal Trials A and B continued to receive acitretin in an open fashion for up to 24 weeks. At the end of the treatment period, all efficacy variables, as indicated in Table 2, were significantly improved ( u2264 0.01) from baseline, including extent of psoriasis, mean ratings of psoriasis severity, and physicianu2019s global evaluation.
Table 2. Summary of the First Course of Therapy with n- Acitretin (24 Weeks)
P
The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physicianu2019s global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a 7-point scale (0=none, 1=trace, 2=mild, 3=mild-moderate, 4=moderate, 5=moderate-severe, 6=severe).
All efficacy variables improved significantly in a subset of 55 subjects from Trial A treated for a second, 6-month maintenance course of therapy (for a total of 12 months of treatment); a small subset of subjects (n=4) from Trial A continued to improve after a third 6-month course of therapy (for a total of 18 months of treatment).

Acitretin capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules, USP should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed u2014 acitretin capsules, USP can cause severe birth defects).
Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.

Pregnancy Category X:
(See boxed .)
Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS: Hepatotoxicity, WARNINGS: Lipids and Possible nCardiovascular Effects, and PRECAUTIONS).
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see ).
Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see u00a0: Pseudotumor Cerebri).
Acitretinn- is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria)u00a0to the preparation (acitretin or excipients) or to other retinoids.

(See also boxedu00a0.)
Skeletal Abnormalities:
In adults receiving long-term treatment with acitretin, appropriate examinations should be periodically performed in view of possible ossification abnormalities (see ADVERSE REACTIONS). Because the frequency and severity of iatrogenic bony abnormality in adults is low, periodic radiography is only warranted in the presence of symptoms or long-term use of acitretin. If such disorders arise, the continuation of therapy should be discussed with the patient on the basis of a careful risk/benefit analysis. In clinical trials with acitretin, subjects were prospectively evaluated for evidence of development or change in bony abnormalities of the vertebral column, knees, and ankles.
Of 380 subjects treated with acitretin, 15% had preexisting abnormalities of the spine which showed new changes or progression of preexisting findings. Changes included degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of a cervical disc space. De novo changes (formation of small spurs) were seen in 3 subjects after 1u00bd to 2u00bd years.
Six of 128 subjects treated with acitretin showed abnormalities in the knees and ankles before treatment that progressed during treatment. In 5, these changes involved the formation of additional spurs or enlargement of existing spurs. The sixth subject had degenerative joint disease which worsened. No subjects developed spurs de novo. Clinical complaints did not predict radiographic changes.
Lipids and Possible Cardiovascular Effects:
Blood lipid determinations should be performed before acitretin is administered and again at intervals of 1 to 2 weeks until the lipid response to the drug is established, usually within 4 to 8 weeks. In subjects receiving acitretin during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% of subjects. These effects of acitretin were generally reversible upon cessation of therapy.
Subjects with an increased tendency to develop hypertriglyceridemia included those with disturbances of lipid metabolism, diabetes mellitus, obesity, increased alcohol intake, or a familial history of these conditions. Because of the risk of hypertriglyceridemia, serum lipids must be more closely monitored in high-risk patients and during long-term treatment.
Hypertriglyceridemia and lowered HDL may increase a patientu2019s cardiovascular risk status. Although no causal relationship has been established, there have been postmarketing reports of acute myocardial infarction or thromboembolic events in patients on therapy with acitretin. In addition, elevation of serum triglycerides to greater than 800 mg per dL has been associated with fatal fulminant pancreatitis. Therefore, dietary modifications, reduction in dose of acitretin, or drug therapy should be employed to control significant elevations of triglycerides. If, despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of acitretin should be considered.
Ophthalmologic Effects:
The eyes and vision of 329 subjects treated with acitretin were examined by ophthalmologists. The findings included dry eyes (23%), irritation of eyes (9%), and brow and lash loss (5%). The following were reported in less than 5% of subjects: Bellu2019s palsy, blepharitis and/or crusting of lids, blurred vision, conjunctivitis, corneal epithelial abnormality, cortical cataract, decreased night vision, diplopia, itchy eyes or eyelids, nuclear cataract, pannus, papilledema, photophobia, posterior subcapsular cataract, recurrent sties, and subepithelial corneal lesions.u00a0
Any patient treated with acitretin who is experiencing visual difficulties should discontinue the drug and undergo ophthalmologic evaluation.
Pancreatitis:
Lipid elevations occur in 25% to 50% of subjects treated with acitretin. Triglyceride increases sufficient to be associated with pancreatitis are much less common, although fatal fulminant pancreatitis has been reported. There have been rare reports of pancreatitis during therapy with acitretin in the absence of hypertriglyceridemia.
Pseudotumor Cerebri:
Acitretin and other retinoids administered orally have been associated with cases of pseudotumor cerebri (benign intracranial hypertension). Some of these events involved concomitant use of isotretinoin and tetracyclines. However, the event seen in a single patient receiving acitretin was not associated with tetracycline use. Early signs and symptoms include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these signs and symptoms should be examined for papilledema and, if present, should discontinue acitretin immediately and be referred for neurological evaluation and care. Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see u00a0).
Capillary Leak Syndrome:n- u00a0n- u00a0
Capillary leak syndrome, a potential manifestation of retinoic acid syndrome, has been reported in patients receiving acitretin. Features of this syndrome may include localized or generalized edema with secondary weight gain, fever, and hypotension. Rhabdomyolysis and myalgias have been reported in association with capillary leak syndrome, and laboratory tests may reveal neutrophilia, hypoalbuminemia, and an elevated hematocrit. Discontinue acitretin if capillary leak syndrome develops during therapy.
Exfoliative Dermatitis/Erythroderma:n- u00a0n- u00a0
Exfoliative dermatitis/erythroderma has been reported in patients receiving acitretin .Discontinue acitretin if exfoliative dermatitis/erythroderma occurs during therapy.

A description of the materials is provided below. The main goals of the materials are to explain the program requirements, to reinforce the educational messages, and to assess program effectiveness.
The includes:
The also includes a voluntary patient survey for women of childbearing potential to assess the effectiveness of the n materials are available at or may be requested by calling 1-877-994-6729.
Information for Patients:
(See Medication Guide for all patients and Patient Agreement/Informed Consent for Female Patients at end of professional labeling.)
Patients should be instructed to read the Medication Guide supplied as required by law when acitretin capsules are dispensed.
Arrayn- Females of Reproductive Potential:
Acitretin can cause severe birth defects.
Females of reproductive potential should also be advised that they must not ingest beverages or products containing ethanol while taking acitretin and for 2 months after acitretin has been discontinued.
Female patients should be advised that any method of birth control can fail, including tubal ligation, and that microdosed progestin u201cminipillu201d preparations are recommended for use with acitretin (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions). Data from one patient who received a very low-dosed progestin contraceptive (levonorgestrel 0.03 mg) had a significant increase of the progesterone level after 3 menstrual cycles during acitretin treatment.n
u00a0Female patients should sign a consent form prior to beginning therapy with acitretin (see boxed CONTRAINDICATIONS AND WARNINGS).
Arrayn- Nursing Mothers:
Studies on lactating rats have shown that etretinate is excreted in the milk. There is one prospective case report where acitretin is reported to be excreted in human milk. Therefore, nursing mothers should not receive acitretin prior to or during nursing because of the potential for serious adverse reactions in nursing infants.
Arrayn- All Patients:
Depression and/or other psychiatric symptoms such as aggressive feelings or thoughts of self-harm have been reported.
Patients should be advised that a transient worsening of psoriasis is sometimes seen during the initial treatment period. Patients should be advised that they may have to wait 2 to 3 months before they get the full benefit of acitretin, although some patients may achieve significant improvements within the first 8 weeks of treatment as demonstrated in clinical trials.
Decreased night vision has been reported during therapy with acitretin. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. Visual problems should be carefully monitored (see WARNINGS and ADVERSE REACTIONS). Patients should be advised that they may experience decreased tolerance to contact lenses during the treatment period and sometimes after treatment has stopped.
Patients should not donate blood during and for at least 3 years following therapy because acitretin can cause birth defects and women of childbearing potential must not receive blood from patients being treated with acitretin.
Because of the relationship of acitretin to vitamin A, patients should be advised against taking vitamin A supplements in excess of minimum recommended daily allowances to avoid possible additive toxic effects.
Patients should avoid the use of sun lamps and excessive exposure to sunlight (non-medical UV exposure) because the effects of UV light are enhanced by retinoids.
Patients should be advised that they must not give their acitretin capsules to any other person.
Arrayn- For Prescribers:
Acitretin has not been studied in and is not indicated for treatment of acne.
Arrayn- Phototherapy:
Significantly lower doses of phototherapy are required when acitretin is used because effects on the stratum corneum induced by acitretin can increase the risk of erythema (burning) (see DOSAGE AND ADMINISTRATION).
Drug Interactions:
Arrayn- Ethanol:
Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and CLINICAL PHARMACOLOGY: Pharmacokinetics).
Arrayn- Glyburide:
In a trial of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the trial with 6 healthy male volunteers in the absence of glyburide did not detect an effect of acitretin on glucose tolerance. Careful supervision of diabetic patients under treatment with acitretin is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION).
Arrayn- Hormonal Contraceptives:
It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin u201cminipillu201d preparations. Microdosed u201cminipillu201d progestin preparations are not recommended for use with acitretin (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions). n n n
Arrayn- Methotrexate:
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see CONTRAINDICATIONS).
Arrayn- Phenytoin:
If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced.
Arrayn- Tetracyclines:
Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see CONTRAINDICATIONS and WARNINGS: Pseudotumor Cerebri).
Arrayn- Vitamin A and Oral Retinoids:
Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A.
Arrayn- Other:
There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
Laboratory Tests:
If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.
Arrayn- Blood Sugar:
Some patients receiving retinoids have experienced problems with blood sugar control. In addition, new cases of diabetes have been diagnosed during retinoid therapy, including diabetic ketoacidosis. In diabetics, blood-sugar levels should be monitored very carefully.
Arrayn- Lipids:
In clinical trials, the incidence of hypertriglyceridemia was 66%, hypercholesterolemia was 33%, and that of decreased HDL was 40%. Pretreatment and follow-up measurements should be obtained under fasting conditions. It is recommended that these tests be performed weekly or every other week until the lipid response to acitretin has stabilized (see WARNINGS).
Arrayn- Liver Function Tests:
Elevations of AST (SGOT), ALT (SGPT), or LDH were experienced by approximately 1 in 3 patients treated with acitretin. It is recommended that these tests be performed prior to initiation of therapy with acitretin, at 1- to 2-week intervals until stable, and thereafter at intervals as clinically indicated (see CONTRAINDICATIONS and boxed WARNINGS).
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Arrayn- Carcinogenesis:
A carcinogenesis study of acitretin in Wistar rats, at doses up to 2 mg per kg per day administered 7 days per week for 104 weeks, has been completed. There were no neoplastic lesions observed that were considered to have been related to treatment with acitretin. An 80-week carcinogenesis study in mice has been completed with etretinate, the ethyl ester of acitretin. Blood level data obtained during this study demonstrated that etretinate was metabolized to acitretin and that blood levels of acitretin exceeded those of etretinate at all times studied. In the etretinate study, an increased incidence of blood vessel tumors (hemangiomas and hemangiosarcomas at several different sites) was noted in male, but not female, mice at doses approximately one-half the maximum recommended human therapeutic dose based on a mg-per-mcomparison.
Arrayn- Mutagenesis:
Acitretin was evaluated for mutagenic potential in the Ames test, in the Chinese hamster (V79/HGPRT) assay, in unscheduled DNA synthesis assays using rat hepatocytes and human fibroblasts, and in an mouse micronucleus assay. No evidence of mutagenicity of acitretin was demonstrated in any of these assays.
Arrayn- Impairment of Fertility:
In a fertility study in rats, the fertility of treated animals was not impaired at the highest dosage of acitretin tested, 3 mg per kg per day (approximately one-half the maximum recommended therapeutic dose based on a mg-per-mcomparison). Chronic toxicity studies in dogs revealed testicular changes (reversible mild to moderate spermatogenic arrest and appearance of multinucleated giant cells) in the highest dosage group (50 then 30 mg per kg per day).
No decreases in sperm count or concentration and no changes in sperm motility or morphology were noted in 31 men (17 psoriatic subjects, 8 subjects with disorders of keratinization, and 6 healthy volunteers) given 30 to 50 mg per day of acitretin for at least 12 weeks. In these trials, no deleterious effects were seen on either testosterone production, LH, or FSH in any of the 31 men.No deleterious effects were seen on the hypothalamic-pituitary axis in any of the 18 men where it was measured.n
Pregnancy:
Arrayn- Teratogenic Effects:
Pregnancy Category X (see boxed CONTRAINDICATIONS AND WARNINGS).
In a study in which acitretin was administered to male rats only at a dosage of 5 mg per kg per day for 10 weeks (approximate duration of one spermatogenic cycle) prior to and during mating with untreated female rats, no teratogenic effects were observedin the progeny (see boxed CONTRAINDICATIONS AND WARNINGS for information about male use of acitretin).
Arrayn- Nonteratogenic Effects:
In rats dosed at 3 mg per kg per day (approximately one-half the maximum recommended therapeutic dose based on a mg-per-m comparison), slightly decreased pup survival and delayed incisor eruption were noted. At the next lowest dose tested, 1 mg per kg per day, no treatment-related adverse effects were observed.
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established. No clinical trials have been conducted in pediatric subjects. Ossification of interosseous ligaments and tendons of the extremities, skeletal hyperostoses, decreases in bone mineral density, and premature epiphyseal closure have been reported in children taking other systemic retinoids, including etretinate, a metabolite of acitretin. A causal relationship between these effects and acitretin has not been established. While it is not known that these occurrences are more severe or more frequent in children, there is special concern in pediatric patients because of the implications for growth potential (see WARNINGS: Hyperostosis).
Geriatric Use:
Clinical trials of acitretin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. A 2-fold increase in acitretin plasma concentrations was seen in healthy elderly subjects compared with young subjects, although the elimination half-life did not change (see CLINICAL PHARMACOLOGY: Special Populations).

Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of acitretin resemble those of the hypervitaminosis A syndrome.
Adverse Events/Postmarketing Reports:
In to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of acitretin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Arrayn- Cardiovascular:
Acute myocardial infarction, thromboembolism (see ), stroke.
Arrayn- Array
Hypersensitivity, including angioedema and urticaria (see ).
Arrayn- Nervous System:
Myopathy with peripheral neuropathy has been reported during therapy with acitretin. Both conditions improved with discontinuation of the drug.
Arrayn- Psychiatric:
Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking acitretin. Since other factors may have contributed to these events, it is not known if they are related to acitretin (see ).
Arrayn- Reproductive:
Vulvo-vaginitis due to .
Arrayn- Skin and Appendages:
Thinning of the skin, skin fragility, and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed. Madarosis and exfoliative dermatitis/erythroderma have been reported (see ).
Arrayn- Vascular Disorders:
Arrayn- Clinical Trials:
During clinical trials with acitretin, 513 of 525 (98%)u00a0subjects reported a total of 3,545 adverse events. One-hundred sixteen subjects (22%) left trials prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three subjects died. Two of the deaths were not drug-related (pancreatic adenocarcinoma and lung cancer); the other subject died of an acute myocardial infarction, considered remotely related to drug therapy. n
The tables below list by body system and frequency the adverse events reported during clinical trials of 525 subjects with psoriasis.
Table 3. Adverse Events Frequently Reported during Clinical TrialsPercent of Subjects Reporting (N = 525)
Table 4. Adverse Events Less Frequently Reported during Clinical Trials (Some of Whichu00a0n- May Bear No Relationship to Therapy) n- Percent of Subjects Reporting (N = 525)
Arrayn- Laboratory:
Therapy with acitretin induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 subjects treated with acitretin. In most subjects, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In subjects receiving acitretin during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% (see WARNINGS). Transient, usually reversible elevations of alkaline phosphatase have been observed.
Table 5 lists the laboratory abnormalities reported during clinical trials.
u00a0u00a0u00a0 Table 5. Abnormal Laboratory Test Results Reported during Clinical Trialsn n- u00a0u00a0u00a0u00a0 Percent of Subjects Reporting
To report SUSPECTED ADVERSE EVENTS, contactu00a0Impax Laboratories, Inc. at 1-877-994-6729 or FDA at 1-800-FDA-1088 or n- Arrayn- for voluntary reporting of adverse reactions.

In the event of acute overdosage, acitretin must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A (e.g., headache and vertigo). The acute oral toxicity (LD) of acitretin in both mice and rats was greater than 4,000 mg per kg.
In one reported case of overdose, a 32-year-old male with Darieru2019s disease took 21 x 25 mg capsules (525 mg single dose). He vomited several hours later but experienced no other ill effects.
All female patients of childbearing potential
1) Have a pregnancy test at the time of overdose; 2) Be counseled as per the boxed u00a0andu00a0u00a0sections regarding birth defects and contraceptive use for at least 3 yearsu2019 duration after the overdose.

There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with acitretin. A number of the more common side effects are dose-related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Therapy with acitretin should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patientu2019s response to initial treatment. Relapses may be treated as outlined for initial therapy.
When acitretin is used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patientu2019s individual response (seeu00a0: General).
Females who have taken TEGISONn- (etretinate) must continue to follow the contraceptive recommendations for TEGISONn- . TEGISONn- is no longer marketed in the US; for information, callu00a0Impax Laboratories, Inc. at 1-877-994-6729.
Information for Pharmacists:
Acitretin must only be dispensed in no more than a monthly supply.u00a0 An Acitretin Medication Guide must be given to the patient each time acitretin is dispensed, as required by law.

White to off-white body and a brown cap, 10 mg, imprinted in black u201cWPIu201d on the capsule cap and u201c2263u201d on the capsule body; bottles of 30 (NDC 0115-1667-08).
Yellow to light yellow body and cap, 17.5 mg, imprinted in black u201cWPIu201d on the capsule cap and u201c2264u201d on the capsule body; bottles of 30 (NDC 0115-1668-08).
Brown body and cap, 22.5 mg, imprinted in black with u201cWPIu201d on the capsule cap and u201c2265u201d on the capsule body; bottles of 30 (NDC 0115-1698-08). u00a0
Yellow to light yellow body and a brown cap, 25 mg, imprinted in black u201cWPIu201d on the capsule cap and u201c2266u201d on the capsule body; bottles of 30 (NDC 0115-1669-08).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

1. n- Arch Dermatol Res n- 2. n- Lancet n- 3. n- Dermatology n- 4. n- Dermatologica n- 5. n- Andrologia n- 6.
Manufactured by:n Via CantonaleCH-6996 Ponte CremenagaLugano Switzerland
Distributed by:n Hayward, California 94544
Revised: November 2016LA-1788-02

Arrayn- To be completed by the patient* and signed by her prescriber
Arrayn- Array
*Must also be initialed by the parent or guardian of a minor patient (under age 18).
Read each item below and initial in the space provided to show that you understand each item.
Do not sign this consent and do not take acitretin if there is anything that you do not understand.
u00a0___________________________________________________________________________________________u00a0(Patient's name)
1.
INITIAL: ___________
2.
INITIAL: ___________
3.
INITIAL: ___________
4. n- at the same time.
INITIAL: ___________
5.
INITIAL: ___________
6.
INITIAL: ___________
7.
INITIAL: ___________u00a0n
8.
INITIAL: ___________
9.
INITIAL: ___________
10. n- sure
INITIAL: ___________
11.
INITIAL: ___________
12.
INITIAL: ___________
13.
INITIAL: ___________
14.
INITIAL: ___________
15.
INITIAL: ___________
I have received a copy of the Education and Pregnancy Prevention for Acitretin (EPPA) Program Booklet. My prescriber has answered all my questions about acitretin. I understand that it is my responsibility to follow my doctoru2019s instructions, and not to get pregnant during treatment with n- acitretinu00a0or for at least 3 years after I stop taking acitretin.
I now authorize my prescriber, ______________________________________________, to begin my treatment with acitretin.
Patient signature: ________________________________________
Date: ___________________
Parent/guardian signature (if under age 18): ____________________
Date: ___________________
Please print: Patient name and address: ______________________________________________________________________________
_______________________________________________________________
Telephone: _____________________________________________________________
I have fully explained to the patient, _______________________________________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with acitretin and have answered those questions to the best of my ability.
Prescriber signature: _______________________________________
Date: __________________
Revised:u00a0November 2016

Read this Medication Guide carefully before you start taking acitretin and read it each time you get more acitretin. There may be new information.
The first information in this Guide is about birth defects and how to avoid pregnancy. n ALL patients should read this entire Medication Guide carefully.
This information does not take the place of talking with your prescriber about your medical condition or treatment.
Arrayn- Array
Acitretin can cause serious side effects, including:
1n- . Severe birth defects.
Arrayn- Array
2n- . Liver problems,
u00a0n n n n n u2022 n u2022 n n n n Avoiding alcohol is very important, because alcohol changes acitretin into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you swallow any form of alcohol during treatment with acitretin and for 2 months after you stop taking acitretin. u2022 n n n A negative result shows you are not pregnant. Because it takes a few days after pregnancy begins for a test to show that you are pregnant, the first negative test may not ensure you are not pregnant. Do not start acitretin until you have negative results from 2 pregnancy tests. u2022 The (urine or blood)u00a0will be done at the time you and your prescriber decide if acitretin might be right for you. u2022 The will usually be done during the first 5 days of your menstrual period.u00a0u00a0 You must start taking acitretin within 7 days of when the urine or blood for the second pregnancy test is collected.u2022 After you start taking acitretin, you must have a pregnancy test repeated each month that you are taking acitretin. This is to be sure that you are not pregnant during treatment because acitretin can cause birth defects.u00a0 In addition, your prescription of acitretin will be limited to a monthly supply. u2022 For at least 3 years after stopping treatment with acitretin, you must have a pregnancy test repeated every 3 months to make sure that you are not pregnant. u2022 u2022 for at least 1 month before beginning treatment with acitretin u2022 during treatment with acitretinu2022 for at least 3 years after stopping treatment with acitretinu2022 n
u2022 n n
The following are considered effective forms of birth control:n n
Arrayn- Secondary Forms (use with a Primary Form):n
Arrayn- u2022 If you have sex at any time without using 2 effective forms of birth control (contraception) at the same time, or if you get pregnant or miss your period, stop using n- acitretin and call your prescriber right away. n n- u2022 Consider u201cEmergency Contraceptionu201d (EC) if you have sex with a male without correctly using 2 effective forms of birth control (contraception) at the same time. n- as soon as possible n- Stop taking n- acitretin right away and contact your prescriber if you get pregnant while taking acitretin or at any time for at least 3 years after treatment has stopped. You need to discuss the possible effects on the unborn baby with your prescriber.n n- If you do become pregnant while taking n- acitretin or at any time for at least 3 years after stopping acitretin, you should report your pregnancy tou00a0Impax Generics Medical Information Call Center at 1-877-994-6729 n- or directly to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088. n- Do not take n- acitretin if you are breastfeeding.
Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Because n- acitretin can have serious side effects, n- Arrayn- Arrayn- Do NOT take n- acitretin if you can get pregnant. n- at least 3 years n- Do NOT take n- acitretin if you are breastfeeding. n- Do NOT take n- acitretin if you have severe liver or kidney disease. n n- Do NOT take n- acitretin if you have repeated high blood lipids n- Do NOT take n- acitretin if you take these medicines: n n- Do NOT take n- acitretin if you are allergic to acitretin
Tell your prescriber if you have or ever had:
Your prescriber needs this information to decide if acitretin is right for you and to know what dose is best for you.n including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines can cause serious side effects if taken while you also take acitretin. Some medicines may affect how acitretin works, or acitretin may affect how your other medicines work. n
Tell your prescriber if you are getting phototherapy treatment. n- Arrayn- Arrayn- not n- Arrayn- Arrayn- Avoid pregnancy. n- Avoid breastfeeding. n- Avoid alcohol. n- Avoid giving blood. Do not donate blood n- for at least 3 years after stopping n- Avoid progestin-only birth control pills (u201cminipillsu201d). n- Avoid night driving if you develop any sudden vision problems. n- Avoid non-medical ultraviolet (UV) light. n- Avoid dietary supplements containing vitamin A. n- DO NOT SHARE n- acitretin with anyone else, even if they have the same symptoms. n- Arrayn- Arrayn- . n- See u201cWhat is the most important information I should know about acitretin?u201d n- u201cWhat are the important warnings and instructions for females taking acitretin?u201dn n- Stop taking acitretin and call your prescriber right away if you get the following signs or symptoms of possible serious side effectsn- :n n- Bad headaches, nausea, vomiting, blurred vision. n- Vision problems.u00a0 n- Decreased vision in the dark n- (night blindness). n- Depression. n- Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet. n- Frequent urination, great thirst or hunger. n- Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke. n- u2022 Blood vessel problems. n- Call your prescriber right away if you have any of the following symptoms: n- Serious allergic reactions. n- Call your prescriber right away if you get any of the following symptoms of an allergic reaction: n- If this happens, stop taking an- citretin and do not take it againn- Serious skin problems. n- Call your prescriber right away if your skin becomes red and swollen (inflamed), you have peeling of your skin, or your skin becomes itchy and painfuln- Arrayn- Chapped lips, peeling fingertips, palms, and soles, itching, scaly skin all over, weak nails, sticky or fragile (weak) skin, runny or dry nose, or nosebleeds. n- Dry mouth n n- Joint pain n n- Tight muscles n n- Hair loss. n- Dry eyes. n- contact lenses n- Rise in blood fats (lipids). n- Arrayn- Array
Arrayn- Arrayn- Arrayn- Arrayn- Array
Manufactured by:n Via CantonaleCH-6996 Ponte CremenagaLugano Switzerland
Distributed by:n n Hayward, California 94544
Revised:u00a0November 2016LA-1788-02

NDC 0115-1667-08
Arrayn- Array

u00a0n
Arrayn- Array

NDC 0115-1698-08
Arrayn- Array

u00a0n

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Acitretin (Acitretin)

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