16 HOW SUPPLIED/STORAGE AND HANDLING
Olmesartan medoxomil and hydrochlorothiazide tablets are supplied as follows:
OLM/HCTZ | Shape | Color | Debossing |
Side 1 | Side 2 |
20/12.5 mg
| Round
| Beige | OLH | Plain on other side |
40/12.5 mg
| Oval
| Beige | OLH | 12.5 |
40/25 mg
| Oval
| Pink | OLH | 25 |
Tablets are packaged as follows:
| NDC 70756-xxx-xx |
20/12.5 mg | 40/12.5 mg | 40/25 mg |
Bottle of 30 tablets | 812-30 | 813-30 | 814-30 |
Bottle of 90 tablets | 812-90 | 813-90 | 814-90 |
Bottle of 500 tablets | 812-51 | 813-51 | 814-51 |
Bottle of 1000 tablets | 812-12 | 813-12 | 814-12 |
Storage
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep this and all medicines out of the reach of children.
17 PATIENT COUNSELING INFORMATION
Pregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible
[see Use in Specific Populations (
8.1)].
Symptomatic hypotension and syncope: Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. If syncope occurs advise patients, to contact their healthcare provider.
Potassium Supplements:
Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.
Acute myopia and secondary angle-closure glaucoma:
Advise patients to discontinue olmesartan medoxomil and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma
[see Warnings and Precautions ( 5.6)].
Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
Manufactured by:
Umedica Laboratories Pvt. Ltd. Plot No. 221 and 221/1, GIDC, IInd Phase,
Vapi, Gujarat 396195, India (IND).
Made in India
Manufactured for:
Lifestar Pharma LLC
1200 MacArthur Blvd.
Mahwah, NJ 07430 USA
Revised: May 2023, V-04
*The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt. Ltd. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Ltd. or its products.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20 mg/12.5 mg- NDC 70756-812-30 -30s Bottle Label
Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/12.5 mg- NDC 70756-813-90 -90s Bottle Label
Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg- NDC 70756-814-12 -1000s Bottle Label
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet |
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OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet |
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OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet |
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Revised: 12/2023 Lifestar Pharma LLC