FELODIPINEEXTENDED-RELEASE TABLETS (Page 5 of 5)
Clinical Laboratory Test Findings
Serum Electrolytes — No significant effects on serum electrolytes were observed during short- and long-term therapy (see CLINICAL PHARMACOLOGY, Renal/Endocrine Effects).
Serum Glucose — No significant effects on fasting serum glucose were observed in patients treated with felodipine extended-release tablets in the U.S. controlled study.
Liver Enzymes — 1 of 2 episodes of elevated serum transaminases decreased once drug was discontinued in clinical studies; no follow-up was available for the other patient.
OVERDOSAGE
Oral doses of 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality.
In a suicide attempt, one patient took 150 mg felodipine together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient’s blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly bradycardia.
If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated. The administration of intravenous fluids may be useful to treat hypotension due to overdosage with calcium antagonists. In case of accompanying bradycardia, atropine (0.5-1 mg) should be administered intravenously. Sympathomimetic drugs may also be given if the physician feels they are warranted.
It has not been established whether felodipine can be removed from the circulation by hemodialysis.
To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.
DOSAGE AND ADMINISTRATION
The recommended starting dose is 5 mg once a day. Depending on the patient’s response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5 — 10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS). Modification of the recommended dosage is usually not required in patients with renal impairment.
Felodipine extended-release tablets should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism). Felodipine extended-release tablets should be swallowed whole and not crushed or chewed.
Geriatric Use
Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.
Patients with Impaired Liver Function
Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets (see CLINICAL PHARMACOLOGY).
HOW SUPPLIED
No.3584 — Felodipine extended-release tablets, 2.5 mg, are sage green, round convex tablets, with code 450 on one side and PLENDIL on the other. They are supplied as follows:
NDC 63304-435-01 bottles of 100
No.3585 — Felodipine extended-release tablets, 5 mg, are light red-brown, round convex tablets, with code 451 on one side and PLENDIL on the other. They are supplied as follows:
NDC 63304-436-01 bottles of 100
No.3586 — Felodipine extended-release tablets, 10 mg, are red-brown, round convex tablets, with code 452 on one side and PLENDIL on the other. They are supplied as follows:
NDC 63304-437-01 bottles of 100
Storage
Store below 30°C (86°F). Keep container tightly closed. Protect from light.
PLENDIL is a trademark of the Astrazeneca group of companies
Whitehouse Station, NJ, 08889, USA
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
2.5 mg_- 100’S BOTTLE LABEL
5 mg — 100’S BOTTLE LABEL
10 mg — 100’S BOTTLE LABEL
| FELODIPINEEXTENDED-RELEASE TABLETS felodipine tablet, extended release | ||||||||||||||||||
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| Labeler — Ranbaxy Pharmaceuticals Inc (937890044) |
| Registrant — Astrazeneca Limited Partnership (785395237) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Ranbaxy Pharmaceuticals Inc | 937890044 | relabel | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Merck & Co Inc | 001317064 | manufacture | |
Revised: 09/2009 Ranbaxy Pharmaceuticals Inc
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