Invagen Pharmaceuticals, Inc.,
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Invagen Pharmaceuticals, Inc., Drugs
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![Zolpidem Tartrate (Zolpidem Tartrate) Tablet For Oral Use – Civ [Invagen Pharmaceuticals Inc.,]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
Zolpidem Tartrate
2.1 Dosage in adults
The dose of zolpidem tartrate tablets should be individualized.
The recommended dose for adults is 10 mg immediately before bedtime.
Zolpidem tartrate tablets should not be administered with or immediately after a meal.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate tablets. Patients with hepatic insufficiency do not clear the drug as rapidly as normals. An initial 5 mg dose is recommended in these patients [see Warnings and Precautions (5)].
2.3 Administration with CNS depressants:
Downward dosage adjustment may be necessary when zolpidem tartrate tablets are administered with agents having known CNS-depressant effects because of the potentially additive effects [see Warnings and Precautions (5)].
2.4 Maximum daily dose:
The total zolpidem tartrate tablet dose should not exceed 10 mg per day.
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Ramipril
Blood pressure decreases associated with any dose of ramipril depend, in part, on the presence or absence of volume depletion (e.g., past and current diuretic use) or the presence or absence of renal artery stenosis. If such circumstances are suspected to be present, the initial starting dose should be 1.25 mg once daily.
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 alone, a diuretic can be added.
After the initial dose of ramipril, 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 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 with potassium supplements, potassium salt substitutes, or potassiumsparing 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. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with ramipril. (See WARNINGS.) Then, if blood pressure is not controlled with ramipril alone, diuretic therapy should be resumed.
If the diuretic cannot be discontinued, an initial dose of 1.25 mg ramipril 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 once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg.
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Hydralazine Hydrochloride
Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels.
The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE.
In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.
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