Tretinoin (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tretinoin Capsules, 10 mg are available as two-piece hard gelatin capsule with brown opaque cap and dark yellow opaque body, filled with yellow viscous oily suspension. Imprinted in black ink with stylized barr 808. Available in bottles of 100 capsules (NDC 0555-0808-02).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep this and all medications out of the reach of children.

Protect from light.

17 PATIENT 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 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].

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 [see Use in Specific Populations (8.3)].

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 [see Use in Specific Populations (8.3)].

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 [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.3)].

Leukocytosis
Inform patients that rapidly evolving leukocytosis, which can be life-threatening, can occur during treatment with tretinoin capsules [see Warnings and Precautions (5.4)].

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 [see Warnings and Precautions (5.5)].

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 [see Warnings and Precautions (5.6)].

Hepatotoxicity
Advise patients that tretinoin capsules can cause elevated liver function tests. Advise patients on the need for monitoring of liver function tests [see Warnings and Precautions (5.7)].

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 [see Warnings and Precautions (5.8)].

Lactation
Advise women not to breastfeed during treatment with tretinoin capsules and for 1 week after the last dose [see Use in Specific Populations (8.2)].

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 [see Dosage and Administration (2.2)].

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.

Brands listed are the trademarks of their respective owners.

Manufactured For:
Teva Pharmaceuticals Parsippany, NJ 07054

Rev. C 2/2023

PRINCIPAL DISPLAY PANEL

NDC 0555-0808-02

Tretinoin Capsules 10 mg

Rx Only

100 Capsules

10 mg
(click image for full-size original)
TRETINOIN tretinoin capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0555-0808
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRETINOIN (TRETINOIN) TRETINOIN 10 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
GELATIN
HYDROGENATED SOYBEAN OIL
POLYSORBATE 80
SOYBEAN OIL
ALPHA-TOCOPHEROL
WHITE WAX
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color brown, yellow (dark yellow) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code barr;808
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0555-0808-02 100 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077684 06/26/2007
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 02/2023 Teva Pharmaceuticals USA, Inc.

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