Ramipril (Page 7 of 7)

Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

Ramipril capsules should be given at an initial dose of 2.5 mg, once a day for 1 week, 5 mg, once a day for the next 3 weeks, and then increased as tolerated, to a maintenance dose of 10 mg, once a day. If the patient is hypertensive or recently post myocardial infarction, it can also be given as a divided dose.

Hypertension

The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with ramipril capsules alone, a diuretic can be added.

After the initial dose of ramipril capsules, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ramipril capsules does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

The ramipril capsule is usually swallowed whole. The ramipril capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of apple sauce or mixed in 4 oz. (120 ml) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, the mixture should be consumed in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration.

Concomitant administration of ramipril capsules with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium. (See PRECAUTIONS.)

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of ramipril capsules. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with ramipril capsules. (See WARNINGS.) Then, if blood pressure is not controlled with ramipril capsules alone, diuretic therapy should be resumed.

If the diuretic cannot be discontinued, an initial dose of 1.25 mg ramipril capsules should be used to avoid excess hypotension.

Dosage Adjustment in Renal Impairment

In patients with creatinine clearance <40 ml/min/1.73m2 (serum creatinine approximately >2.5 mg/dl) doses only 25% of those normally used should be expected to induce full therapeutic levels of ramiprilat. (See CLINICAL PHARMACOLOGY.)

Hypertension: For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ramipril capsules once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg.

HOW SUPPLIED

Ramipril is available in potencies of 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules.

Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap. The body has “RP 2.5″ and the cap has “>” both printed in black:
bottles of 30 (NDC 21695-821-30).

Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap. The body has “RP 5″ and the cap has “>” both printed in black:
bottles of 30 (NDC 21695-822-30).

Ramipril 10 mg capsules are supplied hard gelatin capsules with white opaque body and blue opaque cap. The body has “RP 10″ and the cap has “>” both printed in black:
bottles of 30 (NDC 21695-823-30).

Dispense in well-closed container with safety closure.
Store at controlled room temperature, 20 to 25o C (68 to 77o F) with excursions permitted between 15 to 30o C (59 to 86o F). (See USP).

Manufactured for: Cobalt Laboratories, Bonita Springs, Florida, U.S.A., 34134

Item Number: LFT0129AB
Date: May 2009

Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Representative Sample of Label — 2.5 mg

Rx only

NDC 21695-821-30

RAMIPRIL CAPSULES

2.5 mg

30 capsules

Rebel Distributors

Ramipril 2.5mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Representative Sample of Label — 5 mg

Rx only

NDC 21695-822-30

RAMIPRIL CAPSULES

5 mg

30 capsules

Rebel Distributors

Ramipril 5mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Representative Sample of Label — 10 mg

Rx only

NDC 21695-823-30

RAMIPRIL CAPSULES

10 mg

30 capsules

Rebel Distributors

Ramipril 10mg
(click image for full-size original)
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-821(NDC:16252-571)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ramipril (ramipril) ramipril 2.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
gelatin
titanium dioxide
D&C YELLOW NO. 10
FD&C RED NO. 40
D&C RED NO. 28
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE (white opaque body and orange opaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RP;2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-821-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076549 12/26/2007
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-822(NDC:16252-572)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ramipril (ramipril) ramipril 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
gelatin
titanium dioxide
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C RED NO. 28
D&C YELLOW NO. 10
Product Characteristics
Color RED (white opaque body and red opaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RP;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-822-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076529 12/26/2007
RAMIPRIL
ramipril capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-823(NDC:16252-573)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ramipril (ramipril) ramipril 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
gelatin
titanium dioxide
FD&C BLUE NO. 1
D&C RED NO. 28
FD&C RED NO. 40
FERROSOFERRIC OXIDE
Product Characteristics
Color BLUE (white opaque body and blue opaque cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code RP;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-823-30 30 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076549 12/26/2007
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 11/2010 Rebel Distributors Corp

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