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Ibasyl Injection

NAFDAC Reg. No. A4-100707 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Ibasyl Injection
NAFDAC number
A4-100707
Active ingredient
Pentazocine (Pentazocine Lactate)
Strength
30 mg/mL
Form
Solution for injection
Pack size
1 mL x 10's (in glass ampoules)
Manufacturer
Not listed
Applicant (holder)
Al-Samparda Pharmaceuticals Nigeria Limited
Approved
31 Jan 2024
Status
Active View on NAFDAC ↗
Registration valid to
30 Jan 2029
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Ibasyl Injection is on the NAFDAC register with an active registration (A4-100707). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Ibasyl Injection is used for

From the official U.S. FDA label for pentazocine (pentazocine lactate), the active ingredient registered with NAFDAC.

Boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PENTAZOCINE AND NALOXONE TABLETS Addiction, Abuse, and Misuse Because the use of Pentazocine and Naloxone Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [ see
What it is used for

Pentazocine and Naloxone Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Possible side effects

The following adverse reactions associated with the use of Pentazocine and Naloxone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular - Hypertension, hypotension, circulatory depression, tachycardia, syncope. Respiratory - Rarely, respiratory depression. Acute CNS Manifestations - Hallucinations (usually visual), disorientation, and confusion. …

Do not use if

Pentazocine and Naloxone Tablets are contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ]. Patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Patients with hypersensitivity to either pentazocine, naloxone, or any of the formulation excipients (e.g., anaphylaxis) [see WARNINGS ].

Warnings

Addiction, Abuse, and Misuse Pentazocine and Naloxone Tablets contain pentazocine, a Schedule IV controlled substance. As an opioid, Pentazocine and Naloxone Tablets expose users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Pentazocine and Naloxone Tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. …

Pregnancy & breastfeeding

Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings ]. There are no available data with Pentazocine and Naloxone Tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Ibasyl Injection

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Ibasyl Injection

What is in Ibasyl Injection?

Ibasyl Injection contains Pentazocine (Pentazocine Lactate) (30 mg/mL), as solution for injection, according to its NAFDAC registration record.

Is Ibasyl Injection registered with NAFDAC?

Yes. Ibasyl Injection is listed on the NAFDAC register under registration number A4-100707, and its registration is active as of 28 October 2026.

Has Ibasyl Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Ibasyl Injection in our automatically synced alert list.

How can I check that my pack of Ibasyl Injection is genuine?

Run a free authenticity scan with the NAFDAC number A4-100707, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Ibasyl Injection used for?

Pentazocine and Naloxone Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Pentazocine and Na (Summarised from the official U.S. FDA label for pentazocine (pentazocine lactate). Always follow your doctor or pharmacist.)

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