Artesunate Suppositories 100mg | Artemisinin Antimalarial Rectal Medication

Artesunate Suppositories 100mg: What the Published Guidance Says

Artemisinin-based combination therapy is the WHO-recommended backbone of falciparum malaria treatment.

Artesunate Suppositories 100mg is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Malaria & ACTs range overview.

• Pre-referral rectal artesunate buys time in the first 24 hours Because the risk of death from severe malaria is greatest during the first day, WHO recommends a single pre-referral dose by the parenteral or intrarectal route. Artesunate suppositories are given at 10 mg/kg as a single dose, in 50 mg or 200 mg formulations. The Model List carries a 100 mg rectal dosage form, restricted to pre-referral treatment of severe malaria only. WHO — Malaria case management: operations manual
• For severe malaria, parenteral artesunate is the drug of choice WHO guidance is artesunate 2.4 mg/kg by intravenous or intramuscular injection on admission, again at 12 and 24 hours, then once daily. Where artesunate is unavailable, intramuscular artemether 3.2 mg/kg on admission followed by 1.6 mg/kg daily is the alternative — artemether must never be given by the intravenous route. Parenteral treatment continues for at least 24 hours before switching to a full three-day oral ACT course. WHO — Malaria case management: operations manual
• ACT is the treatment of choice in all trimesters For uncomplicated P. falciparum malaria, MSF medical guidelines state the treatment of choice in all trimesters is an artemisinin-based combination therapy taken for three days. Co-formulated and co-blistered regimens are both described, including artemether/lumefantrine 20/120 mg and 80/480 mg, artesunate/amodiaquine, artesunate/mefloquine and dihydroartemisinin/piperaquine. MSF Medical Guidelines — Malaria (Chapter 4.3, Parasitic infections)

These points are quoted because they shape how Artesunate Suppositories 100mg is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.

Artesunate Suppositories 100mg — Supply Parameters

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Artemether 80mg Injection, Artesunate 20mg + Pyronaridine 60mg Granules, Chloroquine Phosphate 500mg Tablets, Dihydroartemisinin 40mg + Piperaquine 320mg Tablets, Sulfadoxine/Pyrimethamine 175mg + Amodiaquine 75mg, Sulfadoxine Pyrimethamine 175mg + Dihydroartemisinin 60mg, Artesunate 200mg + Amodiaquine 600mg Tablets, Artesunate 400mg Mefloquine 500mg Tablets.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Artesunate Suppositories 100mg is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

• Testing for description and identification
• Testing for assay of the active substance
• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)
• Testing for uniformity of dosage units
• Testing for water content and pH where applicable

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

• Pack size: Individually sealed suppositories (blister or foil pouch); typically 10 suppositories per box. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store in a cool place (below 25°C), protected from light. Keep away from heat. Keep suppositories in their sealed packaging until use..
• Shelf life: 36 months (unopened, when stored as directed). Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.

• CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
• Site Master File and GMP certificate for the manufacturing workshops.
• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.

This page describes Artesunate Suppositories 100mg as a product of the ACT regimens named in the WHO Model List of Essential Medicines family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.

Related Malaria & ACTs Products

• Artemether 80mg Injection — 80mg
• Artesunate 20mg + Pyronaridine 60mg Granules — 20mg
• Chloroquine Phosphate 500mg Tablets — 500mg
• Dihydroartemisinin 40mg + Piperaquine 320mg Tablets — 40mg
• Sulfadoxine/Pyrimethamine 175mg + Amodiaquine 75mg — 175mg
• Sulfadoxine Pyrimethamine 175mg + Dihydroartemisinin 60mg — 175mg

Browse the full Malaria & ACTs range; all Suppositories; the complete product catalogue.