Generic Name
Clindamycin
Brand Names
Tretinoin, Renova, Cleocin, Clindesse, ZIANA, Altreno, Clindagel, Atralin, Clindamycin Phoaphate, Tri-Luma, Clindacin, Twyneo, Xaciato, Retin-A, ClindaCare, Clindacin ETZ, Onexton, Neuac, Acanya
FDA approval date: May 22, 1970
Classification: Lincosamide Antibacterial
Form: Solution, Lotion, Injection, Suppository, Cream, Aerosol, Kit, Granule, Powder, Swab, Capsule, Gel
What is Tretinoin (Clindamycin)?
TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
Approved To Treat
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Brand Information
Tretinoin (Tretinoin)
WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME
- Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose
- Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution
1INDICATIONS AND USAGE
Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
2DOSAGE FORMS AND STRENGTHS
Capsules: 10 mg, two-tone (lengthwise) with reddish-brown opaque and yellow gelatin shell, imprinted with “TR” with black ink on the yellow side.
3CONTRAINDICATIONS
Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. Reactions have included rash, pruritus, face edema, and dyspnea
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Differentiation Syndrome
- Leukocytosis
- Intracranial hypertension
- Lipid abnormalities
- Hepatotoxicity
- Thromboembolic events
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Acute Promyelocytic Leukemia
The safety of tretinoin capsules was evaluated in patients with APL who received tretinoin capsules at a dose of 22.5 mg/m
The most common adverse reactions (≥30%) were headache, fever, skin/mucous membrane dryness, bone pain, malaise, shivering, upper respiratory tract disorders, dyspnea, hemorrhage, infections, nausea/vomiting, rash, peripheral edema, leukocytosis, pain, gastrointestinal hemorrhage, chest discomfort, abdominal pain.
Table 1 summarizes the adverse reactions for patients with APL.
Table 1. Adverse Reactions (≥ 10%) Occurring in Patients with APL Who Received Tretinoin Capsules
1Differentiation syndrome can be associated with other commonly reported events
such as fever, leukocytosis, dyspnea, pneumonia, pleural effusion, pericardial effusion,
hypotension, edema, weight gain, and renal failure.
such as fever, leukocytosis, dyspnea, pneumonia, pleural effusion, pericardial effusion,
hypotension, edema, weight gain, and renal failure.
Adverse reactions that occurred in <10% of patients who received tretinoin capsules include:
- Hepatobiliary disorders: Hepatosplenomegaly (9%), hepatitis (3%), unspecified liver disorder (3%).
- Musculoskeletal and connective tissue disorders: Flank pain (9%), bone inflammation (3%).
- Nervous system disorders: Agitation (9%), cerebral hemorrhage (9%), intracranial hypertension (9%), hallucination (6%), abnormal gait, agnosia, aphasia, asterixis, cerebellar edema, cerebellar disorders, convulsions, coma, CNS depression, dysarthria, encephalopathy, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, no light reflex, neurologic reaction, spinal cord disorder, stroke, tremor, leg weakness, unconsciousness, dementia, forgetfulness, somnolence, and slow speech (3% each).
- Renal and urinary disorders: Dysuria (9%), acute renal failure, micturition frequency, renal tubular necrosis, and enlarged prostate (3% each).
- Respiratory, thoracic and mediastinal disorders: Lower respiratory tract disorders (9%), pulmonary infiltration (6%), bronchial asthma, pulmonary edema, larynx edema, and unspecified pulmonary disease (3% each).
- Infections and infestations: Cellulitis (8%).
- Blood and lymphatic system disorders: Lymph disorders (6%).
- Cardiovascular disorders: Cardiac failure (6%), cardiac arrest, myocardial infarction, enlarged heart, heart murmur, myocarditis, pericarditis, and secondary cardiomyopathy (3% each).
- Ear and labyrinth disorders: Hearing loss and other unspecified auricular disorders (6%), irreversible hearing loss (<1%).
- General disorders: Face edema (6%), pallor (6%), hypothermia (3%).
- Metabolism and nutrition disorders: Fluid imbalance (6%), acidosis (3%).
- Eye disorders: Changed visual acuity (6%), visual field defects (3%).
- Gastrointestinal disorders: Ascites, ulcer (3% each).
- Vascular disorders: Ischemia and pulmonary hypertension (3% each).
4.2Postmarketing Experience
Because these reactions 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.
Erythema nodosum, basophilia and hyperhistaminemia, Sweet’s Syndrome, organomegaly, hypercalcemia, pancreatitis, myositis, thrombosis (both venous and arterial), thrombocytosis, genital ulceration and vasculitis, predominantly involving the skin.
5OVERDOSAGE
In case of overdose with tretinoin capsules, reversible signs of hypervitaminosis A (headache, nausea, vomiting, mucocutaneous symptoms) can appear. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia. These symptoms have quickly resolved without apparent residual effects.
There is no specific treatment in the case of an overdose; however, it is important that the patient be treated in a special hematological unit.
6DESCRIPTION
Tretinoin is a retinoid. The chemical name is all-trans retinoic acid. The molecular formula is C
It is a yellow to light orange, crystalline powder with melting point at about 182°C (with decomposition). Tretinoin is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in ethanol (96%).
Tretinoin capsules are available as capsules containing 10 mg tretinoin for oral use. Each capsule also contains butylated hydroxyanisole, edetate disodium, soybean oil, hydrogenated vegetable oils, medium chain triglycerides, soya lecithin, and yellow beeswax. The gelatin capsule shell contains gelatin, glycerin, yellow iron oxide, red iron oxide and titanium dioxide. Capsules are printed with edible black ink, which consist of propylene glycol, iron oxide black, polyvinyl acetate phthalate and polyethylene glycol 400.
7CLINICAL STUDIES
The efficacy of tretinoin capsules has been evaluated in 114 previously treated patients and in 67 previously untreated (“de novo”) patients with APL in one open-label, uncontrolled single investigator clinical study (Memorial Sloan-Kettering Cancer Center [MSKCC]) and in two cohorts of compassionate cases treated by multiple investigators under the auspices of the National Cancer Institute (NCI). Patients received tretinoin capsules 22.5 mg/m
Table 2. Efficacy Results in a Controlled Clinical Trial (MSKCC) and Compassionate Use
NR = Not Reached
NA = Not Available
*Including 9 chemorefractory patients
†Including 8 patients who received chemotherapy but failed to enter remission
The median time to complete remission was between 40 and 50 days (range: 2 to 120 days). Most patients received cytotoxic chemotherapy during the remission phase.
Ten of 15 pediatric cases achieved complete remission (8 of 10 males and 2 of 5 females).
8HOW SUPPLIED/STORAGE AND HANDLING
Tretinoin capsules are supplied as 10 mg capsules, two-tone (lengthwise) with reddish-brown opaque and yellow gelatin shell, imprinted with “TR” with black ink on the yellow side. Supplied
Bottles of 100 capsules, NDC 0904-6867-60
Carton of 30 capsules (10 capsules each blister pack x 3), NDC 0904-6867-04
Store at 20ºC to 25ºC (68ºF to 77ºF); [see USP Controlled Room Temperature].
Keep bottle tightly closed. Protect from light.
9PATIENT COUNSELING INFORMATION
Embryo-Fetal Toxicity
Advise female patients of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use 2 methods of effective contraception during treatment with tretinoin capsules and for 1 month after the last dose
Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose
Differentiation Syndrome
Advise patients that tretinoin capsules can cause differentiation syndrome. Ask patients to immediately report any symptoms suggestive of differentiation syndrome, such as fever, cough or difficulty breathing, decreased urinary output, low blood pressure, rapid weight gain, or swelling of their arms or legs, to their healthcare provider for further evaluation
Patients Without t(15;17) Translocation or PML/RARα Fusion
Advise patients that tretinoin capsules are not recommended for use in patients without t(15;17) translocation or PML/RARα fusion
Leukocytosis
Inform patients that rapidly evolving leukocytosis, which can be life-threatening, can occur during treatment with tretinoin capsules
Intracranial Hypertension
Advise patients that tretinoin capsules can cause intracranial hypertension, especially in pediatric patients. Ask patients to immediately report any symptoms suggestive of intracranial hypertension, such as headache, nausea, vomiting, and visual disturbances
Lipid Abnormalities
Inform patients that hypercholesterolemia and/or hypertriglyceridemia can occur during treatment with tretinoin capsules. Advise patients on the need for monitoring fasting triglycerides and cholesterol
Hepatotoxicity
Advise patients that tretinoin capsules can cause elevated liver function tests. Advise patients on the need for monitoring of liver function tests
Thromboembolic Events
Inform patients that venous and arterial thromboembolic events, including cerebrovascular accident, myocardial infarction and renal infarct can occur during treatment with tretinoin capsules
Lactation
Advise women not to breastfeed during treatment with tretinoin capsules and for 1 week after the last dose
Administration Instructions
Advise patients to swallow tretinoin capsules whole with water. Advise patients not to chew, dissolve, or open capsules. Advise patients not to take a missed dose of tretinoin capsules unless it is more than 10 hours until the next scheduled dose. Advise patients that if vomiting occurs after tretinoin capsules administration, that they should not take an additional dose, but continue with the next scheduled dose
Effects on Ability to Drive and Use Machines
Advise patients that the ability to drive or operate machinery might be impaired when treated with tretinoin capsules, particularly if patients are experiencing dizziness or severe headache.
Manufactured for:
Packaged and Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 USA
Refer to package label for Distributor's NDC Number
Made in France
© 2024 Endo, Inc. or one of its affiliates.
Revised: 03/2025
10Package/Label Display Panel
MAJOR®
NDC 0904-6867-04
Unit Dose
Tretinoin
Capsules
10 mg
Contains the active ingredient found in Vesanoid*
Pharmacist: Dispense with Patient
Information Leaflet
PATIENT: READ INFORMATION LEAFLET CAREFULLY
CAUSES BIRTH DIFECTS. DO NOT GET PREGNANT.
30 CAPSULES (3 x 10)
Rx only
