Drug Information

Drug Interaction:

Digoxin

Concurrent administration of hydroxychloroquine and digoxin has been reported to increase serum digoxin levels. Monitor digoxin levels. Hydroxychloroquine sulphate may also be subject to several known interations of cholroquine even though reports have not been recorded.

These include- - potentation of its direct blocking at the neuromuscular nunction by aminoglucosides antibiotcs - inhibition of of its metabolism by cimetidine which may increase plasma conc. of antimalarial - antagonism effect of neostigmine & pyridostigmine , - reduction of antibody response to primary immunisation with intradermal human-diplod cell rabies vaccine Antacids may reduce absorption of hydroxychloroquine so it is advised that a 4 hour interval be observed between hydrxychloroquine and antacid dosing Concurrent use of penicillamine with hydroxychloroquine may increase penicilamine plasma conc. increasing the potential for serious hematological and or renal adverse reactions as well as severe skin reactions

Indication:

U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

3. Hydroxychloroquine 400mg tablets 31-01-08

( Additional Strength)

same as approved

225. Hydroxychloroquine Sulphate 17-10-08

(Addl.Indication)

For the treatment of systemic systemic Lupus

Erythemtosus

Hydroxychloroquine Sulphate USP 400mg tablets (Additional Indication)

Indication-

An adjunct to diet and excercise to improve glycemix control of patients

on metformine , sulphonylurea combination in patients with

Type II Diabetes

Approved by FDA on 28-07-2014 (Ref- FDA approved List- 2014)

Hydroxychloroquine Sulphate tablet 300mg (Additional Strength/Indication)

Indication-

Indicated for the treatment of patients with lower body weight i.e. 45 to 60kg

in Rheumatoid arthiritis, Systemic Lupus Erythematosus and

Polymorphic Light eruption

Approved by FDA on 08-09-2014 (Ref- FDA approved List- 2014)

New drugs approved For Marketing by Drug Controller General of India(DCGI )

during the period January 1988 to November 2014

(Ref- IDMA Annual Publication 2015)

Name of Drug Indication Date of Approval

1.Hydroxychloroquine Sulphate 31-01-2008

USP 400mg tablets

(Additional Indication)

Same as approved

2.Hydroxychloroquine sulphate 17-10-2008

(Addl.Indn.)

For the treatment of systemic lupus erythematosus

3.Hydroxychloroquine sulphate 07-08-2014

Tablet 300mg ( Addl.Indn.)

For the treatment of patients with lower body weight i.e, 45 to 60kg

in rheumatoid arthiritis, systemic lupus erythamatus & polymorphic

light eruption

4.Hydroxychloroquine sulphate USP 28-07-2014

400mg tablets

(Addl.Indcn.)

As an adjunct to diet and excercise to improve glycemic control

of patients on Metaformin, Sulfonyl urea combination in patients

with Type II diabetes

Acute or chronic rheumatoid arthiritis Systemic and discoid lupus erythamatosus

Adverse Reaction:

CNS:

irritability, nervousness, emotional changes, nightmares, psychosis, headache, dizziness, vertigo, tinnitus, nystagmus, nerve deafness, convulsions, ataxia.

Cornea:

transcient edema, decreased corneal sensitivity. Optic disc pallor and atrophy, attentuation of retinal arterioles. Pericentral or paracentral scotoma with decreased visual acuity. Retinopathy, reading and seeing difficulties. Bleaching of hair, alopecia, pruritus, skin and mucosal pigmentation, skin eruptions.

Contra-Indications:

Retinal or visual changes attributable to ant 4-aminoquinoline compound, hypersens to 4-aminoquinline compounds; long term therapy in children.

Special precautions:

Perform periodic blood cell counts during prolonged therapy. If severe blood disorder appears, consider discontinuation. Use caution in G-6-PD deficiency. Use with caution in alcoholic patients Excercise care when given to patients receiving a drug with significant tendency to produce dermatitis. If severe toxic symptoms occur, administer ammonium chloride(8 g daily in divided doses for adults) 3 to 4 days a week for several months after therapy is stopped.

Dosages/ Overdosage Etc:

Indications:

Systemic llipus erythematous, rheumatoid arthritis, malaria.

Dosage:

Rheumatoid arthritis- Initial- adults- 400 to 600 mg daily,taken with meal or glass of milk

Maintenance- Adults- After good response,reduce dosage by 50% at a level of 200 to 400 mg daily.

Children- a dose of 3 to 5 mg/kg/day upto a maximum of 400 mg/day( given once or twicw daily). Do not exceed a dose of 7 mg/kg/day.

Lupus erythematosis- 400mg once or twice daily in adults,continued for several weeks or months.

Maintenace dose- 200 to 400 mg daily. Retinopathy is reported if the maintenance dose is exceeded.

Patient Information:

Ref - USP PDI Vol II 17th Edition (1997)

1.Allergies-

Tell your doctor if you have ever had any unusual or allergic reaction to

hydroxychloroquine. Also tell your healthcare care professional if you are allergic

to any other substances such as foods. preservatives or dyes.

2.Pregnancy-

Unless you are taking for malaria or liver disease by protozoa, use of this

medicine is not recommended during pregnancy.

3. Breast-feeding-

Babies and children are specially sensitive to the effects of hydroxychloroquine.

4.Children-

Children are especially sensitive to the efects of hydroxychloroquine.

5.Older adults-

There is no specific information comparing use of hydroxychloroquine

in the elderly with use in other age groups

6. Other medicines-

Tell your doctor if you are using any other prescription or

non-prescription (Over-the counter) OTC medicine.

7. Other medical problems-

The presence of other medical problems may affect the use of

hydroxychloroquine. Make sure you tell your doctor if you have any other

medical problems especially-

Blood disease- hydroxyquinine may cause blood disorder

Eye or vision problem- hydroxyquinine may cause serious eye side

effects

G6PD patients- hydroxyquinine may cause serious side effects

Liver disease- may decrease removal of hydroxyquinine from the

blood , increasing the chance of side effects

Nerve or brain disease- hydroxyquinine may cause muscle weakness

and in high doses, seizures

Psoriasis- hydroxyquinine may bring severe attacks of spsoriasis

Stomach or intestinal disease- hydroxyquinine may cause severe

stomach irritation

Pharmacology/ Pharmacokinetics:

Pharmacology:

A 4-aminoquinoline compd with antimalarial actions similar to those of chloroquine. It seem to act by suppression of formation of antigens responsible for hypersensitivity reactions.

Pharmacokinetics:

Readily absorbed from GI tract,peak plasma concentrations occur in 1 to 3 hours. The drug concentrates in the liver, spleen, kidney, heart, lung and the brain. About 50% of the unchanged is excreted in the urine.

Interaction with Food:

Not significant.

Pregnancy and lactation:

Pregnancy:

Avoid use during pregnancy

Lactation- A very low concentration of the drug appears in the breast milk.

Children:

Are very sensitive to the drug. Use with extreme caution.

Hydroxychloroquine sulfate @ Antirheumatic Agents(Jan 2008)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation