Chloroquine Phosphate (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The dosage of chloroquine phosphate is often expressed in terms of equivalent chloroquine base. Each 250 mg tablet of chloroquine phosphate contains the equivalent of 150 mg chloroquine base. In infants and children the dosage is preferably calculated by body weight.
Prophylaxis against chloroquine-sensitive Plasmodium species
Adult Dose: The dosage for prophylaxis is 250 mg (= 150 mg base) administered once per week on exactly the same day of each week.
Pediatric Dose: The dosage for prophylaxis is 5 mg calculated as base, per kg of body weight, administered once per week on exactly the same day of each week. The pediatric dose should never exceed the adult dose regardless of weight.
If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this in adults, an initial double (loading) dose of 1 g (= 600 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.

Treatment of uncomplicated malaria due to chloroquine-sensitive Plasmodium species

Adults: An initial dose of 1 g salt (= 600 mg base) followed by an additional 500 mg (= 300 mg base) after six to eight hours and a single dose of 500 mg (= 300 mg base) on each of two consecutive days. This represents a total dose of 2.5 g chloroquine phosphate or 1.5 g base in three days.
Infants and Children: In infants and children, the recommended dose is 10 mg base/kg followed by 5 mg based/kg at 6, 24 and 36 hours (total dose 25 mg based/kg). The pediatric dose should never exceed the adult dose regardless of weight.
The dosage for adults of low body weight and for infants and children should be determined as follows:
First dose: 10 mg base per kg (but not exceeding a single dose of 600 mg base).
Second dose: (6 hours after first dose) 5 mg base per kg (but not exceeding a single dose of 300 mg base).
Third dose: (24 hours after first dose) 5 mg base per kg.
Fourth dose: (36 hours after first dose) 5 mg base per kg.
P. vivax and P. ovale: Concomitant therapy with an 8-aminoquinoline compound is necessary for treatment of the hypnozoite liver stage forms of the parasites.
Extraintestinal Amebiasis: Adults Dosage: 1 g salt (600 mg base) daily for two days, followed by 500 mg (300 mg base) daily for at least two to three weeks. Treatment is usually combined with an effective intestinal amebicide.
Geriatric Use
See PRECAUTIONS, Geriatric Use.

HOW SUPPLIED

Product: 50090-4967

NDC: 50090-4967-3 40 TABLET in a BOTTLE

REFERENCES

  1. Marmor MF, Kellner U, and Lai TY, et al. Recommendations on Screening for Chloroquine
    and Hydroxychloroquine Retinopathy (2016 Revision). Ophthalmology 2016. Doi10.1016./
    jophtha.2016.01.058
  2. Ullberg S, Lindquist N G, Sjostrand S E: Accumulation of chorioretinotoxic drugs in the foetal eye. Nature 1970; 227: 1257.

Rx Only

Manufactured by:
NATCO PHARMA LIMITED

Kothur- 509 228,
India.

Manufactured for:
Rising Pharmaceuticals Inc.
Saddle Brook, NJ 07663
Rev: 02-Feb/2018 346151

Chloroquine Phosphate

Label ImageLabel Image
CHLOROQUINE PHOSPHATE chloroquine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4967(NDC:64980-177)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROQUINE PHOSPHATE (CHLOROQUINE) CHLOROQUINE PHOSPHATE 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-White) Score 2 pieces
Shape ROUND (Round, bi-convex) Size 10mm
Flavor Imprint Code CN250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4967-3 40 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091621 07/01/2011
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4967), REPACK (50090-4967)

Revised: 03/2020 A-S Medication Solutions

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