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dolutegravir sodium

Pharmaranks rates Dolutegravir Sodium 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Dolutegravir Sodium is a human immunodeficiency virus integrase strand transfer inhibitor used to treat Hiv Infections.

Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor · by Macleods Pharms Ltd

Generic of Tivicay

70/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 20, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Active ingredient
Dolutegravir Sodium
Form
Tablet
Strength
Dolutegravir Sodium EQ 10MG Base · Dolutegravir Sodium EQ 25MG Base · Dolutegravir Sodium EQ 50MG Base
Type
Prescription (Rx)
Brand or generic
Generic
Half-life
about 14 hours (how long it stays in your system)
FDA application
ANDA214397
Availability
Discontinued (per FDA)

How long does Dolutegravir Sodium stay in your body?

The elimination half-life of dolutegravir sodium is about 14 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life, which the TIVICAY label gives as "approximately 14 hours," based on population pharmacokinetic analyses; the label reports no separate distribution-phase half-life. Dolutegravir is not a prodrug, and the label describes no active metabolite — it is metabolized mainly by UGT1A1 (with some CYP3A) to an ether glucuronide and oxidative metabolites that the label does not characterize as active, and just over half the dose leaves unchanged in the feces. On populations the label names: age had no clinically relevant effect on dolutegravir pharmacokinetics; mild and moderate kidney impairment had no clinically relevant effect on exposure, and in severe kidney impairment (CrCl under 30 mL/min) exposure was actually lower, not higher (AUC down 40%), with too little information to recommend dosing in people on dialysis; in moderate liver impairment (Child-Pugh B) exposure was similar to healthy controls, and severe liver impairment (Child-Pugh C) has not been studied. The label frames these as changes in exposure rather than stating a revised half-life for each group. People with UGT1A1 genotypes conferring poor metabolism had 32% lower clearance and 46% higher AUC. This figure describes how long the drug itself is cleared from plasma — it is not a drug-test detection window (metabolites can be detected far longer) and not dosing guidance.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — TIVICAY (dolutegravir sodium) tablet, film coated — Clinical Pharmacology (12.3).

Drug class

May treat (source: NIH RxClass)

See how Dolutegravir Sodium ranks — best-rated human immunodeficiency virus integrase strand transfer inhibitor for:

Dosage forms

Tablet

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

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Frequently asked questions

What does Dolutegravir Sodium treat?
Dolutegravir Sodium (Dolutegravir Sodium) may be used to treat HIV infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How is Dolutegravir Sodium rated?
pharmaranks gives Dolutegravir Sodium a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
Is there a coupon or discount for Dolutegravir Sodium?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dolutegravir Sodium. To pay less, Dolutegravir Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Dolutegravir Sodium?
Dolutegravir Sodium is marketed by Macleods Pharms Ltd. You can see Macleods Pharms Ltd's full profile, rating, and other products on pharmaranks.
Is Dolutegravir Sodium a brand-name or generic drug?
Dolutegravir Sodium is a generic medication; its active ingredient is Dolutegravir Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Dolutegravir Sodium available over the counter?
No. Dolutegravir Sodium is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Dolutegravir Sodium come in?
Dolutegravir Sodium is currently marketed as tablet, per the FDA's National Drug Code Directory.
What class of drug is Dolutegravir Sodium?
Dolutegravir Sodium is classified as human immunodeficiency virus integrase strand transfer inhibitor, per the FDA's Established Pharmacologic Class.
Is Dolutegravir Sodium FDA-registered?
Dolutegravir Sodium is on record with the U.S. FDA under application number ANDA214397. You can verify this on its official FDA label.
Has Dolutegravir Sodium been recalled by the FDA?
Dolutegravir Sodium has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Dolutegravir Sodium safe?
There's no single safe-or-not verdict. pharmaranks gives Dolutegravir Sodium a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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dolutegravir sodium

70/100