XITHERAM

This brand name is authorized in Nigeria.

Active ingredients

The drug XITHERAM contains a combination of these active pharmaceutical ingredients (APIs):

1	Telmisartan UNII U5SYW473RQ - TELMISARTAN
	Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting.
	Read more about Telmisartan
2	Amlodipine UNII 864V2Q084H - AMLODIPINE BESYLATE
	Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
	Read more about Amlodipine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-100660	Tablet	Xitheram 80/10 Tablet TAB 10 mg; 80 mg 3x10	39 NF-PP-336299 Xitheram 80/10 Tablet Telmisartan 80mg , Amlodipine 10mg Telmisartan (Form A)@ Ph. Eur. 30.00 kg Sodium Hydroxide (Emprove) Ph. Eur. 2.52 kg Povidone (Plasdone K-25) Ph. Eur. 7.20 kg Meglumine Ph. Eur. 9.00 kg Mannitol (Pearlitol 200 SD) Ph. Eur. 108.03 kg Purified water^ Ph. Eur. 240.00 kg Mannitol (Pearlitol 200 SD) Ph. Eur. 19.50 kg Magnesium stearate (Avantor) Ph. Eur. 1.88 kg Sodium Stearyl Fumarate (Alubra PG 100) Ph. Eur. 1.88 kg Amlodipine Besilate@ Ph. Eur. 3.47 kg Mannitol (Pearlitol 200 SD) Ph. Eur. 34.50 kg Mannitol (Pearli A4-100660 Drugs Imported Products 310 Prescription Only Medicine (POM) 6/13/2023 MAY & BAKER NIGERIA PLC, SAPARA STREET, INDUSTRIAL ESTATE, IKEJA LAGOS LAGOS 18980079 tooluwasanmi@gmail.com Inventia Healthcare Limited, Unit 703 & 704, 7th Floor Hubtown Solaris NS Phadke Marg Andheri (East) Mumbai 400 069, India	21/12/2023
A4-100661	Tablet	Xitheram 40/5 Tablet TAB 5 mg; 40 mg 3x10	38 NF-PP-336559 Xitheram 40/5 Tablet Telmisartan 40mg , Amlodipine 5mg Telmisartan (Form A)@ 40.00 Sodium Hydroxide (Emprove) 3.36 Povidone (Plasdone K-25) 9.60 Meglumine 12.00 Mannitol (Pearlitol 200 SD) 144.04 Purified water^ 320.00 Mannitol (Pearlitol 200 SD) 26.00 Magnesium stearate (Avantor) 2.50 Sodium Stearyl Fumarate (Alubra PG 100) 2.50 Amlodipine Besilate@ 6.94 Mannitol (Pearlitol 200 SD) 144.94 Mannitol (Pearlitol 25 C) 20.00 Iron Oxide Yellow (Sicovit 10 E172) 0.003 Iron Oxide Black 0.30 Brilliant Blue FCF (Koelow-901) 0.00 A4-100661 Drugs Imported Products 310 Prescription Only Medicine (POM) 6/13/2023 MAY & BAKER NIGERIA PLC, SAPARA STREET, INDUSTRIAL ESTATE, IKEJA LAGOS LAGOS 18980079 tooluwasanmi@gmail.com Inventia Healthcare Limited, Unit 703 & 704, 7th Floor Hubtown Solaris NS Phadke Marg Andheri (East) Mumbai 400 069, India	21/12/2023

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
C09DB04	Telmisartan and amlodipine	C Cardiovascular system → C09 Agents acting on the renin-angiotensin system → C09D Angiotensin II antagonists, combinations → C09DB Angiotensin II antagonists and calcium channel blockers
Discover more medicines within C09DB04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
NG	Registered Drug Product Database	A4-100660, A4-100661