Emtricitabine how supplied: Difference between revisions

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==How Supplied/Storage and Handling==


===Capsules===
The size 1 hard gelatin capsules with a blue cap and white body contain 200 mg of emtricitabine, are printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body, and are available in unit of use bottles (closed with induction sealed child-resistant closures) of:
30 capsules (NDC 61958–0601–1).
Store at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F).
===Oral Solution===
The oral solution is a clear, orange to dark orange liquid, contains 10 mg/mL of emtricitabine, and is available in unit of use plastic, amber bottles (closed with child resistant closures and packaged with a marked dosing cup) of:
170 mL (NDC 61958–0602–1).
Store refrigerated, 2 °C–8 °C (36 °F–46 °F). EMTRIVA oral solution should be used within 3 months if stored by the patient at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F).<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d6599395-3944-44f9-97f2-e0424c6b6a1f#nlm34089-3 | publisher =  | date =  | accessdate =  }}</ref>


==References==
==References==

Latest revision as of 16:50, 5 January 2014

Emtricitabine
EMTRIVA® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

How Supplied/Storage and Handling

Capsules

The size 1 hard gelatin capsules with a blue cap and white body contain 200 mg of emtricitabine, are printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body, and are available in unit of use bottles (closed with induction sealed child-resistant closures) of:

30 capsules (NDC 61958–0601–1).

Store at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F).

Oral Solution

The oral solution is a clear, orange to dark orange liquid, contains 10 mg/mL of emtricitabine, and is available in unit of use plastic, amber bottles (closed with child resistant closures and packaged with a marked dosing cup) of:

170 mL (NDC 61958–0602–1).

Store refrigerated, 2 °C–8 °C (36 °F–46 °F). EMTRIVA oral solution should be used within 3 months if stored by the patient at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F).[1]

References

  1. "EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]".

Adapted from the FDA Package Insert.