emtricitabine 200 mg Capsule, 30-count — NDC 69097-642-02 (Billing 69097-0642-02)
This is a package of 30 capsules of emtricitabine 200 mg Capsule from Cipla USA Inc., marketed since Aug 2020 and currently FDA-listed; retail pharmacies pay about $12.69 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 69097-642-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69097 labeler · 642 product · 02 package
- Package marketed since
- Aug 31, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 6909764202 0
- FDA record last changed
- Sep 3, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 052802
- GCN: 20019
- HICL (First Databank): 025426
- AHFS class code: 08:18.08.20
- RxCUI (RxNorm): 403875
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Emtricitabine doesn't cure HIV, but it's an important part of keeping the virus under control. It works by blocking an enzyme HIV needs to make copies of itself. When it's used alo...
- What exactly does emtricitabine do — does it cure HIV?
- Please don't stop without talking to your doctor first. If you also have hepatitis B, stopping emtricitabine can trigger a sudden, severe flare of hepatitis B — sometimes serious e...
- Can I stop taking emtricitabine if I feel fine or if I also have hepatitis B?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Emtricitabine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $12.687 | $380.60 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $12.94 | $388.18 / 30 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 69097-0642-02 You're viewing this Main listing | 30 CAPSULE in 1 BOTTLE | $12.69 / ea | $380.60 | 2020-08-31 | — | Active |
| 69097-0642-15 69097-642-15 | 1000 CAPSULE in 1 BOTTLE | — | — | 2020-08-31 | — | Discontinued by firm |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 69097-0642-15?
What NDC number is used to bill for this package of emtricitabine 200 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| emtricitabine 200 mgthis 69097-0642-02 | Cipla | 30 capsules | $12.687 | AB | Availability likely | — |
| Emtriva 200 mg 61958-0601-01 | Gilead | 30 capsules | $17.446 | AB | Availability likely | +38% |
| Emtricitabine 200 mg 65862-0301-05 | Aurobindo | 500 capsules | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Emtricitabine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Cipla USA Inc. labeler code 69097
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued e mtricitabine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue emtricitabine. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1 )] .
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of Hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued Emtricitabine. Hepatic function should be monitored closely in patients coinfected with HIV-1 and HBV who discontinue Emtricitabine.
If appropriate, initiation of anti-hepatitis B therapy may be warranted. ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Testing: Prior to or when initiating emtricitabine test for hepatitis B virus infection. ( 2.1 ) Emtricitabine may be taken without regard to food. ( 2.2 ) Adult Patients (18 years of age and older) ( 2.3 ): Emtricitabine capsules: One 200 mg capsule administered once daily orally.
Pediatric Patients (3 months through 17 years of age) ( 2.5 ): Emtricitabine capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally. Dose interval adjustment in adult patients with renal impairment ( 2.6 ): a. Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis.
Formulation Creatinine Clearance (mL/min) ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis a Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours
2.1Testing Prior to Initiation of Treatment with Emtricitabine Prior to or when initiating emtricitabine, test patients for hepatitis B virus infection [see Warnings and Precautions ( 5.1 )].
2.2Recommended Dosage Emtricitabine is taken by mouth once daily and may be taken without regard to food [see Clinical Pharmacology ( 12.3 ) ].
2.3Recommended Dosage in Adult Patients (18 years of age and older) Emtricitabine capsules: One 200 mg capsule administered once daily orally.
2.5Recommended Dosage in Pediatric Patients (3 months through 17 years of age) Emtricitabine capsules: For pediatric patients weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.
2.6Dosage Adjustment in Patients with Renal Impairment Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of dose adjustment recommendations in patients with moderate to severe renal impairment (creatinine clearance below 50 mL/min) have not been clinically evaluated.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.6 )] . Table 1. Dose Interval Adjustment for Adult Patients with Altered Creatinine Clearance Formulation Creatinine Clearance (mL/min) ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis a Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours a.
Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. There are insufficient data available to make dosage recommendations in pediatric patients with renal impairment.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Emtricitabine Capsules, containing 200 mg of emtricitabine, are size '1' capsules with sky blue cap imprinted with "EMT" in black and white body imprinted with "200" in black. Capsules: 200 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.2 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.3 )
5.1Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before or when initiating emtricitabine [see Dosage and Administration ( 2.1 )]. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. Patients who are coinfected with HIV-1 and HBV who discontinue emtricitabine should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
If appropriate, initiation of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.
5.2Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including emtricitabine. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus , Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.
5.3Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including FTC, alone or in combination with other antiretrovirals. Treatment with emtricitabine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
5.4Dose Adjustment in Patients with New Onset or Worsening Renal Impairment Emtricitabine is principally eliminated by the kidney. Reduction of the dosage of emtricitabine is recommended for patients with impaired renal function [see Dosage and Administration ( 2.6 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )] .
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions ( 5.1 )] . Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.2 )] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions ( 5.3 )] . Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.
Skin hyperpigmentation was very common (≥10%) in pediatric patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials Experience in Adults More than 2,000 adult subjects with HIV-1 infection have been treated with emtricitabine alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials.
The most common adverse reactions (incidence greater than or equal to 10%, any severity) identified from any of the three large, controlled clinical trials include headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. In Trials 301A and 303, the most common adverse reactions that occurred in subjects receiving emtricitabine with other antiretroviral agents were headache, diarrhea, nausea, and rash, which were generally mild to moderate.
Approximately 1% of subjects discontinued participation in the clinical trials due to these events. All adverse reactions were reported with similar frequency in emtricitabine and control treatment groups except for skin discoloration, which was reported with higher frequency in the emtricitabine treated group. Skin discoloration, manifested by hyperpigmentation on the palms or soles, was generally mild and asymptomatic.
The mechanism and clinical significance are unknown. A summary of emtricitabine treatment-emergent clinical adverse reactions in Trials 301A and 303 is provided in Table 2. Table 2.
Selected Treatment-Emergent Adverse Reactions (All Grades, Regardless of Causality) Reported in ≥ 3% of Emtricitabine-Treated Subjects in Either Trial 301A or 303 (0–48 Weeks) 303 301A Emtricitabine+ AZT/d4T + NNRTI/PI (N=294) 3TC + AZT/d4T + NNRTI/PI (N=146) Emtricitabine + didanosine + EFV (N=286) d4T + didanosine + EFV (N=285) Body as a Whole Asthenia 16% 10% 12% 17% Headache 13% 6% 22% 25% Abdominal pain 8% 11% 14% 17% Digestive System Diarrhea 23% 18% 23% 32% Nausea 18% 12% 13% 23% Vomiting 9% 7% 9% 12% Dyspepsia 4% 5% 8% 12% Musculoskeletal Myalgia 4% 4% 6% 3% Arthralgia 3% 4% 5% 6% Nervous System Insomnia 7% 3% 16% 21% Depressive disorders 6% 10% 9% 13% Paresthesia 5% 7% 6% 12% Dizziness 4% 5% 25% 26% Neuropathy/peripheral neuritis 4% 3% 4% 13% Abnormal dreams 2% <1% 11% 19% Respiratory Rhinitis 18% 12% 12% 10% Increased cough 14% 11% 14% 8% Skin Rash event a 17% 14% 30% 33% AZT=zidovudine; d4T=stavudine; NNRTI/PI=non-nucleoside reverse transcriptase inhibitor/protease inhibitor; 3TC=lamivudine; EFV=efavirenz. a.
Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction. Laboratory Abnormalities: Laboratory abnormalities in these trials occurred with similar frequency in the emtricitabine and comparator groups. A summary of Grades 3-4 laboratory abnormalities is provided in Table 3.
Table 3. Treatment-Emergent Grades 3-4 Laboratory Abnormalities Reported in ≥1% of Emtricitabine-Treated Subjects in Either Trial 30… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The potential for drug interactions with emtricitabine has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling [see Clinical Pharmacology ( 12.3 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended. ( 8.2 ) Pediatrics: Dose adjustment based on age and weight. ( 2.5 , 12.3 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data) .
The rate of miscarriage for individual drugs is not reported in the APR. In the U.S., general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. In animal reproduction studies, no adverse developmental effects were observed when FTC was administered at exposures ≥60 times that of the recommended daily dose of emtricitabine (see Data) .
Data Human Data Based on prospective reports to the APR of exposures to FTC-containing regimens during pregnancy resulting in live births (including over 2,700 exposed in the first trimester and over 1,200 exposed in the second/third trimester), there was no increase between FTC and overall birth defects compared with the background birth defect rate of 2.7% in a U.S. reference population of the MACDP. The prevalence of birth defects in live births was 2.4% (95% CI: 1.9% to 3.1%) with first trimester exposure to FTC-containing regimens and 2.3% (95% CI: 1.5% to 3.3%) with the second/third trimester exposure to FTC-containing regimens.
Prospective reports from the APR of overall major birth defects in pregnancies exposed to FTC are compared with a U.S. background major birth defect rate. Methodologic limitations of the APR include the use of MACDP as the external comparator group. Limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease.
Additionally, published observational studies on FTC exposure in pregnancy have not shown an increased risk for major malformations. Animal Data FTC was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (AUC) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose.
In a pre/postnatal development study in mice, FTC was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended daily dose.
8.2Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1 . Based on published data, FTC has been shown to be present in human breast milk. It is not known if FTC affects milk production or has effects on the breastfed child.
Because of the potential for: (1) HIV transmission (in HIV-negative infants); (2) developing viral resistance (in HIV-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine.
8.4Pediatric Use The safety and efficacy of FTC in patients between 3 months and 21 years of age is supported by data from three open-label,… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data) .
The rate of miscarriage for individual drugs is not reported in the APR. In the U.S., general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. In animal reproduction studies, no adverse developmental effects were observed when FTC was administered at exposures ≥60 times that of the recommended daily dose of emtricitabine (see Data) .
Data Human Data Based on prospective reports to the APR of exposures to FTC-containing regimens during pregnancy resulting in live births (including over 2,700 exposed in the first trimester and over 1,200 exposed in the second/third trimester), there was no increase between FTC and overall birth defects compared with the background birth defect rate of 2.7% in a U.S. reference population of the MACDP. The prevalence of birth defects in live births was 2.4% (95% CI: 1.9% to 3.1%) with first trimester exposure to FTC-containing regimens and 2.3% (95% CI: 1.5% to 3.3%) with the second/third trimester exposure to FTC-containing regimens.
Prospective reports from the APR of overall major birth defects in pregnancies exposed to FTC are compared with a U.S. background major birth defect rate. Methodologic limitations of the APR include the use of MACDP as the external comparator group. Limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease.
Additionally, published observational studies on FTC exposure in pregnancy have not shown an increased risk for major malformations. Animal Data FTC was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (AUC) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose.
In a pre/postnatal development study in mice, FTC was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended daily dose.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of FTC in patients between 3 months and 21 years of age is supported by data from three open-label, nonrandomized clinical trials in which FTC was administered to 169 HIV-1 infected treatment-naive and experienced (defined as virologically suppressed on a 3TC containing regimen for which FTC was substituted for 3TC) subjects [see Clinical Studies ( 14.4 )] . The pharmacokinetics of FTC were studied in 20 neonates born to HIV-1 positive mothers [see Clinical Studies ( 14.4 )] .
All neonates were HIV-1 negative at the end of the trial; the efficacy of FTC in preventing or treating HIV-1 could not be determined.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of emtricitabine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE If overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether FTC can be removed by peritoneal dialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Emtricitabine is an antiretroviral drug [see Microbiology ( 12.4 )].
12.3Pharmacokinetics Adults The pharmacokinetic properties of FTC were evaluated in healthy subjects and HIV- 1-infected subjects. Emtricitabine pharmacokinetics are similar between these populations. Figure 1 shows the mean steady-state plasma FTC concentration-time profile in 20 HIV-1-infected subjects receiving emtricitabine capsules.
Figure 1 Mean (± 95% CI) Steady-State Plasma FTC Concentrations in HIV-1-Infected Adults (N=20) Absorption Emtricitabine is rapidly and extensively absorbed following oral administration, with peak plasma concentrations occurring at 1-2 hours postdose. Following multiple dose oral administration of emtricitabine capsules to 20 HIV-1 infected subjects, the (mean ± SD) steady-state plasma FTC peak concentration (C max ) was 1.8 ± 0.7 µg/mL and the area-under the plasma concentration-time curve over a 24-hour dosing interval (AUC) was 10.0 ± 3.1 µg•hr/mL.
The mean steady-state plasma trough concentration at 24 hours postdose was 0.09 µg/mL. The mean absolute bioavailability of emtricitabine capsules was 93%, while the mean absolute bioavailability of emtricitabine oral solution was 75%. The relative bioavailability of emtricitabine oral solution was approximately 80% of emtricitabine capsules.
The multiple dose pharmacokinetics of FTC are dose proportional over a dose range of 25-200 mg. Distribution In vitro binding of FTC to human plasma proteins was less than 4% and independent of concentration over the range of 0.02-200 µg/mL. At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was ~4.0.
Metabolism Following administration of radiolabelled FTC, complete recovery of the dose was achieved in urine (~86%) and feces (~14%). Thirteen percent (13%) of the dose was recovered in urine as three putative metabolites. The biotransformation of FTC includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
No other metabolites were identifiable. Elimination The plasma FTC half-life is approximately 10 hours. The renal clearance of FTC is greater than the estimated creatinine clearance, suggesting elimination by both glomerular filtration and active tubular secretion.
There may be competition for elimination with other compounds that are also renally eliminated. Effects of Food on Oral Absorption Emtricitabine capsules may be taken with or without food. Emtricitabine systemic exposure (AUC) was unaffected while C max decreased by 29% when emtricitabine capsules were administered with food (an approximately 1000 kcal high-fat meal).
Specific Populations Geriatric Patients The pharmacokinetics of FTC have not been fully evaluated in the elderly (65 years of age and older). Pediatric Patients The pharmacokinetics of FTC at steady state were determined in 77 HIV-1 infected pediatric subjects, and the pharmacokinetic profile was characterized in four age groups (Table 6). The FTC exposure achieved in pediatric subjects receiving a daily dose of 6 mg/kg up to a maximum of 240 mg oral solution or a 200 mg capsule is similar to exposures achieved in adult subjects receiving a once-daily dose of 200 mg.
Table 6. Mean ± SD Pharmacokinetic Parameters by Age Groups for Pediatric Subjects and Neonates Receiving Emtricitabine Capsules HIV-1-exposed Neonates HIV-1-Infected Pediatric Subjects b Mean (range) Age 0-3 mo (N=20) a 3-24 mo (N=14) 25 mo-6 yr (N=19) 7–12yr (N=17) 13–17 yr (N=27) Formulation Capsule (n) 0 0 0 10 26 Dose (mg/kg) b 3.1 (2.9-3.4) 6.1 (5.5-6.8) 6.1 (5.6-6.7) 5.6 (3.1−6.6) 4.4 (1.8−7.0) C max (µg/mL) 1.6 ± 0.6 1.9 ± 0.6 1.9 ± 0.7 2.7 ± 0.8 2.7 ±
0.9AUC (µg•hr/mL) 11.0 ± 4.2 8.7 ± 3.2 9.0 ± 3.0 12.6 ± 3.5 12.6 ±
5.4T 1/2 (hr) 12.1 ± 3.1 8.9 ± 3.2 11.3 ± 6.4 8.2 ± 3.2 8.9 ± 3.3 a Two ph… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Emtricitabine is an antiretroviral drug [see Microbiology ( 12.4 )].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Emtricitabine Capsules 200mg are size '1' capsules with sky blue cap imprinted with "EMT" in black and white body imprinted with "200" in black. Emtricitabine Capsules, 200mg are available as follows: Bottles of 30 capsules (NDC 69097-642-02) Bottles of 1000 capsules (NDC 69097-642-15) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Dispense only in original container.
Keep container tightly closed.
📋 Description ▾
11 DESCRIPTION Emtricitabine USP is a synthetic nucleoside analog with activity against human immunodeficiency virus type 1 (HIV-1) reverse transcriptase. The chemical name of emtricitabine is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine USP is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: Emtricitabine USP is a white to almost white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 ºC. The log P for FTC is -0.43 and the pKa is 2.65.
Emtricitabine capsules are for oral administration. Each capsule contains 200 mg of emtricitabine USP and the inactive ingredients, mannitol, hypromellose, and magnesium stearate. The capsule shell contains the following inactive ingredients and dyes: FD&C blue 1, titanium dioxide, gelatin, and sodium lauryl sulfate.
The capsules are printed with ink containing black iron oxide. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV Inform patients that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and hepatitis B virus (HBV) who have discontinued emtricitabine. Advise patients not to discontinue emtricitabine without first informing their healthcare provider.
All patients should be tested for HBV infection before or when starting emtricitabine and those who are infected with HBV need close medical follow-up for several months after stopping emtricitabine to monitor for exacerbations of hepatitis [see Warnings and Precautions ( 5.1 )]. Immune Reconstitution Syndrome Inform patients that in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Advise patients to inform their healthcare provider immediately of any symptoms of infection [see Warnings and Precautions ( 5.2 )]. Lactic Acidosis and Severe Hepatomegaly Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with emtricitabine should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions ( 5.3 )].
Pregnancy Registry Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to emtricitabine [see Use in Specific Populations ( 8.1 )]. Lactation Instruct mothers not to breastfeed if they are taking emtricitabine because of the risk of passing the HIV-1 virus to the baby [see Use in Specific Populations ( 8.2 )] . Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Ltd.
Manufactured by: Cipla Limited, Verna-403722, Goa, India Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 09/2023
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1 . Based on published data, FTC has been shown to be present in human breast milk. It is not known if FTC affects milk production or has effects on the breastfed child.
Because of the potential for: (1) HIV transmission (in HIV-negative infants); (2) developing viral resistance (in HIV-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Adults The pharmacokinetic properties of FTC were evaluated in healthy subjects and HIV- 1-infected subjects. Emtricitabine pharmacokinetics are similar between these populations. Figure 1 shows the mean steady-state plasma FTC concentration-time profile in 20 HIV-1-infected subjects receiving emtricitabine capsules.
Figure 1 Mean (± 95% CI) Steady-State Plasma FTC Concentrations in HIV-1-Infected Adults (N=20) Absorption Emtricitabine is rapidly and extensively absorbed following oral administration, with peak plasma concentrations occurring at 1-2 hours postdose. Following multiple dose oral administration of emtricitabine capsules to 20 HIV-1 infected subjects, the (mean ± SD) steady-state plasma FTC peak concentration (C max ) was 1.8 ± 0.7 µg/mL and the area-under the plasma concentration-time curve over a 24-hour dosing interval (AUC) was 10.0 ± 3.1 µg•hr/mL.
The mean steady-state plasma trough concentration at 24 hours postdose was 0.09 µg/mL. The mean absolute bioavailability of emtricitabine capsules was 93%, while the mean absolute bioavailability of emtricitabine oral solution was 75%. The relative bioavailability of emtricitabine oral solution was approximately 80% of emtricitabine capsules.
The multiple dose pharmacokinetics of FTC are dose proportional over a dose range of 25-200 mg. Distribution In vitro binding of FTC to human plasma proteins was less than 4% and independent of concentration over the range of 0.02-200 µg/mL. At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was ~4.0.
Metabolism Following administration of radiolabelled FTC, complete recovery of the dose was achieved in urine (~86%) and feces (~14%). Thirteen percent (13%) of the dose was recovered in urine as three putative metabolites. The biotransformation of FTC includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
No other metabolites were identifiable. Elimination The plasma FTC half-life is approximately 10 hours. The renal clearance of FTC is greater than the estimated creatinine clearance, suggesting elimination by both glomerular filtration and active tubular secretion.
There may be competition for elimination with other compounds that are also renally eliminated. Effects of Food on Oral Absorption Emtricitabine capsules may be taken with or without food. Emtricitabine systemic exposure (AUC) was unaffected while C max decreased by 29% when emtricitabine capsules were administered with food (an approximately 1000 kcal high-fat meal).
Specific Populations Geriatric Patients The pharmacokinetics of FTC have not been fully evaluated in the elderly (65 years of age and older). Pediatric Patients The pharmacokinetics of FTC at steady state were determined in 77 HIV-1 infected pediatric subjects, and the pharmacokinetic profile was characterized in four age groups (Table 6). The FTC exposure achieved in pediatric subjects receiving a daily dose of 6 mg/kg up to a maximum of 240 mg oral solution or a 200 mg capsule is similar to exposures achieved in adult subjects receiving a once-daily dose of 200 mg.
Table 6. Mean ± SD Pharmacokinetic Parameters by Age Groups for Pediatric Subjects and Neonates Receiving Emtricitabine Capsules HIV-1-exposed Neonates HIV-1-Infected Pediatric Subjects b Mean (range) Age 0-3 mo (N=20) a 3-24 mo (N=14) 25 mo-6 yr (N=19) 7–12yr (N=17) 13–17 yr (N=27) Formulation Capsule (n) 0 0 0 10 26 Dose (mg/kg) b 3.1 (2.9-3.4) 6.1 (5.5-6.8) 6.1 (5.6-6.7) 5.6 (3.1−6.6) 4.4 (1.8−7.0) C max (µg/mL) 1.6 ± 0.6 1.9 ± 0.6 1.9 ± 0.7 2.7 ± 0.8 2.7 ±
0.9AUC (µg•hr/mL) 11.0 ± 4.2 8.7 ± 3.2 9.0 ± 3.0 12.6 ± 3.5 12.6 ±
5.4T 1/2 (hr) 12.1 ± 3.1 8.9 ± 3.2 11.3 ± 6.4 8.2 ± 3.2 8.9 ± 3.3 a Two pharmacokinetic evaluations were conducted in 20 neonates over the first 3 months of life. Median (range) age of infant o… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Overview of Clinical Trials The efficacy and safety of emtricitabine were evaluated in the trials summarized in Table 10. Table 10 Trials Conducted with Emtricitabine in Adult and Pediatric Subjects Trial Population Trial Arms (N) a Timepoint (Weeks) Trial 934 b (NCT00112047) HIV-1 treatment-naïve adults Emtricitabine+TDF+EFV (227) AZT/3TC+EFV (229) 144 Trial 301A c (NCT00006208) Emtricitabine +didanosine+EFV (286) d4T+didanosine+EFV (285) 48 Trial 303 b (NCT00002416) HIV-1 treatment-experienced adults Emtricitabine +AZT/d4T+NNRTI/PI (294) 3TC+AZT/d4T+NNRTI/PI (146) 48 Trial 202 d (NCT00016718) HIV-1 treatment-naïve and experienced pediatrics Emtricitabine +didanosine+EFV (43) 48 Trial 203 d (NCT00743340) Emtricitabine +d4T+lopinavir/ritonavir (116) 48 Trial 211 d (NCT00642291) Emtricitabine +didanosine+EFV (16) 48 a.
Randomized and dosed. b. Randomized, open-label, active-controlled trial. c. Randomized, double-blind, active-controlled trial. d.
Nonrandomized, open-label trial.
14.2Clinical Trial Results in Treatment-Naive Adults Trial 934 Data through 144 weeks are reported for Trial 934, a randomized, open-label, active-controlled multicenter clinical trial comparing Emtricitabine + TDF administered in combination with EFV versus AZT/3TC fixed-dose combination administered in combination with EFV in 511 antiretroviral-naive subjects. From Weeks 96 to 144 of the trial, subjects received FTC/TDF fixed-dose combination with EFV in place of emtricitabine + TDF with EFV. Subjects had a mean age of 38 years (range 18-80); 86% were male, 59% were Caucasian, and 23% were Black.
The mean baseline CD4 + cell count was 245 cells/mm 3 (range 2-1191) and median baseline plasma HIV-1 RNA was 5.01 log 10 copies/mL (range 3.56-6.54). Subjects were stratified by baseline CD4 + cell count (< or ≥200 cells/mm 3 ); 41% had CD4 + cell counts <200 cells/mm 3 and 51% of subjects had baseline viral loads >100,000 copies/mL. Table 11 provides treatment outcomes through 48 and 144 weeks for those subjects who did not have EFV resistance at baseline.
Table 11 Virologic Outcomes of Randomized Treatment at Week 48 and 144 (Trial 934) a. Subjects who were responders at Week 48 or Week 96 (HIV-1 RNA <400 copies/mL) but did not consent to continue in the trial after Week 48 or Week 96 were excluded from analysis. b. Subjects achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Weeks 48 and 144. c.
Includes confirmed viral rebound and failure to achieve confirmed <400 copies/mL through Weeks 48 and 144. d. Includes lost to follow-up, subject withdrawal, noncompliance, protocol violation and other reasons. Outcomes Week 48 Week 144 Emtricitabine +TDF +EFV (N=244) AZT/3TC +EFV (N=243) Emtricitabine + TDF +EFV (N=227) a AZT/3TC +EFV (N=229) a Responder b 84% 73% 71% 58% Virologic failure c 2% 4% 3% 6% Rebound 1% 3% 2% 5% Never suppressed 0% 0% 0% 0% Change in antiretroviral regimen 1% 1% 1% 1% Death <1% 1% 1% 1% Discontinued due to adverse event 4% 9% 5% 12% Discontinued for other reasons d 10% 14% 20% 22% Through Week 48, 84%, and 73% of subjects in the emtricitabine + TDF group and the AZT/3TC group, respectively, achieved and maintained HIV-1 RNA <400 copies/mL (71% and 58% through Week 144).
The difference in the proportion of subjects who achieved and maintained HIV-1 RNA <400 copies/mL through 48 weeks largely results from the higher number of discontinuations due to adverse events and other reasons in the AZT/3TC group in this open-label trial. In addition, 80% and 70% of subjects in the emtricitabine + TDF group and the AZT/3TC group, respectively, achieved and maintained HIV-1 RNA <50 copies/mL through Week 48 (64% and 56% through Week 144). The mean increase from baseline in CD4 + cell count was 190 cells/mm 3 in the emtricitabine + TDF group and 158 cells/mm 3 in the AZT/3TC group at Week 48 (312 and 271 cells/mm 3 at Week 144).
Through 48 weeks, 7 subjects in the emtricitabine + TDF group and 5 subjects in t… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In long-term oral carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the therapeutic dose). Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test) or mouse lymphoma or mouse micronucleus assays. Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose.
Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human exposures at the recommended 200 mg daily dose.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In long-term oral carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the therapeutic dose). Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test) or mouse lymphoma or mouse micronucleus assays. Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose.
Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human exposures at the recommended 200 mg daily dose.
📄 Patient Package Insert ▾
PATIENT INFORMATION Emtricitabine (em tri SIT uh bean) Capsules What is the most important information I should know about Emtricitabine capsules? Emtricitabine can cause serious side effects, including: Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before starting treatment with emtricitabine.
If you have HBV infection and take emtricitabine, your HBV may get worse (flare-up) if you stop taking emtricitabine. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not stop taking emtricitabine without first talking to your healthcare provider.
Do not run out of emtricitabine. Refill your prescription or talk to your healthcare provider before your emtricitabine is all gone. If you stop taking emtricitabine, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medication to treat hepatitis B.
Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking emtricitabine. For more information about side effects, see the section "What are the possible side effects of emtricitabine?" What are Emtricitabine capsules? Emtricitabine is a prescription medicine used in combination with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Who should not take Emtricitabine capsules? Do not take Emtricitabine capsules if you are allergic to emtricitabine or any of the ingredients in emtricitabine capsules.
See the end of this leaflet for a complete list of ingredients in emtricitabine capusles. What should I tell my healthcare provider before taking emtricitabine? Before taking emtricitabine capsules, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, including HBV infection have kidney problems or receive kidney dialysis treatment are pregnant or planning to become pregnant.
It is not known if Emtricitabine can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with emtricitabine. Pregnancy Registry : There is a pregnancy registry for women who take emtricitabine during pregnancy.
The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. Emtricitabine can pass to your baby in your breast milk.
Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Talk with your healthcare provider about the best way to feed your baby Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with emtricitabine.
Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with emtricitabine. Do not start a new medicine without telling your healthcare provider.
Your healthcare provider can tell you if it is safe to take emtricitabine with other medicines. How should I take Emtricitabine capsules? Take Emtricitabine capsules exactly as your healthcare provider tells you to take it.
Dosing in adults: Take emtricitabine capsules by mouth 1 time each day. Dosing in children: Take emtricitabine capsules by mouth 1 time each day. The child's healthcare provider will calculate the right dose of Emtricitabine capsule based on the child's weight.
Emtricitabine may be taken with or without food. Do not miss a dose of emtricitabine. Missing a dose lowers the amount of medicine in your blood.
Refill your emtricitabine prescription before you run out of medicine. Do not change your dose or stop taking emtri… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Boxed Warning 02/2019 Dosage and Administration Testing Prior to Initiation of Treatment with Emtricitabine ( 2.1 ) 12/2018 Recommended Dosage ( 2.2 ) 02/2019 Dosage Adjustment in Patients with Renal Impairment 02/2019 Warnings and Precautions Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV ( 5.1 ) 12/2018 Coadministration with Related Products Removed 12/2018
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69097-642-02 Rx Only 30 Capsules Emtricitabine Capsules 200 mg Cipla emtri-30s-bottle-label