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Apredin Injection

NAFDAC Reg. No. A4-4875 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Apredin Injection
NAFDAC number
A4-4875
Active ingredient
Hydralazine Hydrochloride
Strength
40 mg/2 mL
Form
Solution for injection
Pack size
2 mL x 10's (in amber coloured glass ampoules)
Manufacturer
Not listed
Applicant (holder)
Embassy Pharmaceutical and Chemicals Limited
Approved
3 Aug 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
2 Aug 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Apredin Injection is on the NAFDAC register with an active registration (A4-4875). 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.

How to use Apredin Injection

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Essential hypertension, alone or as an adjunct.

How to take it and how often
  • Initiate therapy in gradually increasing dosages; adjust according to individual response
  • Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week
  • For the second and subsequent weeks, increase dosage to 50 mg four times daily
  • For maintenance, adjust dosage to the lowest effective levels
  • The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE hydrochloride tablets
  • In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets daily may be required for a significant antihypertensive effect
  • In such cases, a lower dosage of hydrALAZINE hydrochloride tablets combined with a thiazide and/or reserpine or a beta blocker may be considered
  • However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug
Talk to a doctor first if

Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

Warnings

​ In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)

Possible side effects

Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Common Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent: Digestive: constipation, paralytic ileus. Cardiovascular: hypotension, paradoxical pressor response, edema. Respiratory: dyspnea. …

If you take too much

Acute Toxicity: No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally. Oral LD 50 in rats: 173 and 187 mg/kg. Signs and Symptoms Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. Treatment There is no specific antidote. The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-07-01.

Label for hydralazine hydrochloride, the active ingredient registered with NAFDAC.

Check your pack of Apredin Injection

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

3 free checks left today Official sources: NAFDAC · WHO · U.S. FDA · Health Canada · NLM

About Apredin Injection

What is in Apredin Injection?

Apredin Injection contains Hydralazine Hydrochloride (40 mg/2 mL), as solution for injection, according to its NAFDAC registration record.

Is Apredin Injection registered with NAFDAC?

Yes. Apredin Injection is listed on the NAFDAC register under registration number A4-4875, and its registration is active as of 28 October 2026.

Has Apredin Injection been flagged as fake or recalled?

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

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

Run a free authenticity scan with the NAFDAC number A4-4875, 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.

How do I take Apredin Injection?

Follow your prescription or the leaflet in your pack. The official label says: Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence o…

What is Apredin Injection used for?

Essential hypertension, alone or as an adjunct. (Summarised from the official U.S. FDA label for hydralazine hydrochloride. Always follow your doctor or pharmacist.)

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