Dolquine

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Dolquine uses


WARNING

PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING Dolquine.

DESCRIPTION

Dolquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1).

Dolquine (hydroxychloroquine sulfate) tablets contain 200 mg Dolquine sulfate, equivalent to 155 mg base, and are for oral administration.

Inactive Ingredients: Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene glycol 400, Polysorbate 80, Corn Starch, Titanium Dioxide.

ACTIONS

The drug possesses antimalarial actions and also exerts a beneficial effect in lupus erythematosus (chronic discoid or systemic) and acute or chronic rheumatoid arthritis. The precise mechanism of action is not known.

INDICATIONS

Dolquine is indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis.

CONTRAINDICATIONS

Use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.

WARNINGS, General

Dolquine is not effective against chloroquine-resistant strains of P. falciparum.

Before starting a long-term treatment, both eyes should be carefully examined for visual acuity, central visual field and color vision. Examination should also include fundoscopy. These examinations should be repeated at least annually. Retinal toxicity is largely dose-related.

The risk of retinal damage is small with daily doses of up to 6.5 mg/kg body weight. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. This examination should be more frequent and adapted to the patient in the following situations:


If any visual disturbance occurs, the drug should be immediately discontinued and the patient closely observed for possible progression of the abnormality. Retinal changes (and visual disturbances) may progress even after cessation of the therapy.

Suicidal behavior has been reported in very rare cases in patients treated with Dolquine.

Children are especially sensitive to the 4-aminoquinoline compounds. A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses (0.75 g or 1 g in one 3-year-old child). Patients should be strongly warned to keep these drugs out of the reach of children.

Use of Dolquine in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria the condition may be exacerbated. The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.

Usage in Pregnancy

Usage of this drug during pregnancy should be avoided except in the suppression or treatment of malaria when in the judgment of the physician the benefit outweighs the possible hazard. It should be noted that radioactively-tagged chloroquine administered intravenously to pregnant, pigmented CBA mice passed rapidly across the placenta. It accumulated selectively in the melanin structures of the fetal eyes and was retained in the ocular tissues for five months after the drug had been eliminated from the rest of the body.

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PRECAUTIONS, General

Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs.

Periodic blood cell counts should be made if patients are given prolonged therapy. If any severe blood disorder appears which is not attributable to the disease under treatment, discontinuation of the drug should be considered. The drug should be administered with caution in patients having G-6-PD (glucose-6-phosphate dehydrogenase) deficiency.

ADVERSE REACTIONS

Psychiatric disorders: Nervousness, emotional lability, psychosis, suicidal behavior.

Nervous system disorders: Dizziness, headache, convulsions have been reported with this class of drugs.

Eye disorders: Retinopathy with changes in pigmentation and visual field defects have been reported. In its early form, it appears reversible on discontinuation of Dolquine. If allowed to develop, there may be a risk of progression even after treatment withdrawal. Cases of maculopathies and macular degeneration have been reported and may be irreversible.

Skin and subcutaneous tissue disorders: Bullous eruptions including very rare cases of Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity and exfoliative dermatitis have been reported.

OVERDOSAGE

The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes. The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsade de pointe, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required, as these effects may appear shortly after the overdose. Treatment is symptomatic and must be prompt with immediate evacuation of the stomach by emesis (at home, before transportation to the hospital) or gastric lavage until the stomach is completely emptied. If finely powdered, activated charcoal is introduced by the stomach tube, after lavage, and within 30 minutes after ingestion of the tablets, it may inhibit further intestinal absorption of the drug. To be effective, the dose of activated charcoal should be at least five times the estimated dose of Dolquine ingested. Convulsions, if present, should be controlled before attempting gastric lavage. If due to cerebral stimulation, cautious administration of an ultrashort-acting barbiturate may be tried but, if due to anoxia, it should be corrected by oxygen administration, artificial respiration or, in shock with hypotension, by vasopressor therapy. Because of the importance of supporting respiration, tracheal intubation or tracheostomy, followed by gastric lavage, may also be necessary. Exchange transfusions have been used to reduce the level of 4-aminoquinoline drug in the blood.

A patient who survives the acute phase and is asymptomatic should be closely observed for at least six hours. Fluids may be forced, and sufficient ammonium chloride (8 g daily in divided doses for adults) may be administered for a few days to acidify the urine to help promote urinary excretion in cases of both overdosage and sensitivity.

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MALARIA

Actions

Like chloroquine phosphate, USP, Dolquine is highly active against the erythrocytic forms of P. vivax and P. malariae and most strains of P. falciparum.

Dolquine does not prevent relapses in patients with P. vivax or P. malariae malaria because it is not effective against exo-erythrocytic forms of the parasite, nor will it prevent P. vivax or P. malariae infection when administered as a prophylactic. It is highly effective as a suppressive agent in patients with P. vivax or P. malariae malaria, in terminating acute attacks, and significantly lengthening the interval between treatment and relapse. In patients with P. falciparum malaria, it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.

Indications

Dolquine is indicated for the treatment of acute attacks and suppression of malaria.

Warnings

In recent years, it has been found that certain strains of P. falciparum have become resistant to 4-aminoquinoline compounds as shown by the fact that normally adequate doses have failed to prevent or cure clinical malaria or parasitemia. Treatment with quinine or other specific forms of therapy is therefore advised for patients infected with a resistant strain of parasites.

Before starting a long-term treatment, both eyes should be carefully examined for visual acuity, central visual field and color vision. Examination should also include fundoscopy. These examinations should be repeated at least annually. Retinal toxicity is largely dose-related.

The risk of retinal damages is small with daily doses of up to 6.5 mg/kg body weight. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. This examination should be more frequent and adapted to the patient in the following situations:


If any visual disturbance occurs (visual acuity, color vision), the drug should be immediately discontinued and the patient closely observed for possible progression of the abnormality. Retinal changes (and visual disturbances) may progress even after cessation of the therapy.

Suicidal behavior has been reported in very rare cases in patients treated with Dolquine.

Adverse Reactions

Following the administration in doses adequate for the treatment of an acute malarial attack, mild and transient headache, dizziness, and gastrointestinal complaints (diarrhea, anorexia, nausea, abdominal cramps and, on rare occasions, vomiting) may occur. Cardiomyopathy has been rarely reported with high daily dosages of Dolquine.

Psychiatric disorders: Nervousness, emotional lability, psychosis, suicidal behavior.

Nervous system disorders: Dizziness, headache, convulsions have been reported with this class of drugs.

Eye disorders : Retinopathy with changes in pigmentation and visual field defects have been reported. In its early form, it appears reversible on discontinuation of Dolquine. If allowed to develop, there may be a risk of progression even after treatment withdrawal. Cases of maculopathies and macular degeneration have been reported and may be irreversible.

Skin and subcutaneous tissue disorders: Bullous eruptions including very rare cases of Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity and exfoliative dermatitis have been reported.

Dosage and Administration

One tablet of 200 mg of Dolquine sulfate is equivalent to 155 mg base.

Malaria

Suppression

In adults, 400 mg on exactly the same day of each week. In infants and children, the weekly suppressive dosage is 5 mg, calculated as base, per kg of body weight, but should not 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 800 mg (=620 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 the acute attack

In adults, an initial dose of 800 mg (= 620 mg base) followed by 400 mg (=310 mg base) in six to eight hours and 400 mg (=310 mg base) on each of two consecutive days (total 2 g Dolquine sulfate or 1.55 g base). An alternative method, employing a single dose of 800 mg (=620 mg base), has also proved effective.

The dosage for adults may also be calculated on the basis of body weight; this method is preferred for infants and children. A total dose representing 25 mg of base per kg of body weight is administered in three days, as follows:

First dose: 10 mg base per kg (but not exceeding a single dose of 620 mg base).

Second dose: 5 mg base per kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.

Third dose: 5 mg base per kg 18 hours after second dose.

Fourth dose: 5 mg base per kg 24 hours after third dose.

For radical cure of vivax and malariae malaria concomitant therapy with an 8-aminoquinoline compound is necessary.

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LUPUS ERYTHEMATOSUS AND RHEUMATOID ARTHRITIS

Indications

Dolquine is useful in patients with the following disorders who have not responded satisfactorily to drugs with less potential for serious side effects: lupus erythematosus and acute or chronic rheumatoid arthritis.

Warnings

PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRlBlNG Dolquine.

Irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy for discoid and systemic lupus erythematosus, or rheumatoid arthritis.

When prolonged therapy with any Antimalarial compound is contemplated, initial (base line) and periodic (every three months) ophthalmologic examinations (including visual acuity, expert slit-lamp, funduscopic, and visual field tests) should be performed.

If there is any indication of abnormality in the visual acuity, visual field, color vision, or retinal macular areas (such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes and streaks) which are not fully explainable by difficulties of accommodation or corneal opacities, the drug should be discontinued immediately and the patient closely observed for possible progression. Retinal changes (and visual disturbances) may progress even after cessation of therapy.

Retinal toxicity is largely dose-related. The risk of retinal damages is small with daily doses of up to 6.5 mg/kg body weight. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. This examination should be more frequent and adapted to the patient in the following situations:


All patients on long-term therapy with this preparation should be questioned and examined periodically, including the testing of knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs, discontinue the drug.

In the treatment of rheumatoid arthritis, if objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be discontinued. Safe use of the drug in the treatment of juvenile arthritis has not been established.

Suicidal behavior has been reported in very rare cases in patients treated with Dolquine.

Precautions

Dermatologic reactions to Dolquine may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis.

The methods recommended for early diagnosis of "chloroquine retinopathy" consist of funduscopic examination of the macula for fine pigmentary disturbances or loss of the foveal reflex and (2) examination of the central visual field with a small red test object for pericentral or paracentral scotoma or determination of retinal thresholds to red. Any unexplained visual symptoms, such as light flashes or streaks should also be regarded with suspicion as possible manifestations of retinopathy.

If serious toxic symptoms occur from overdosage or sensitivity, it has been suggested that ammonium chloride (8 g daily in divided doses for adults) be administered orally three or four days a week for several months after therapy has been stopped, as acidification of the urine increases renal excretion of the 4-aminoquinoline compounds by 20 to 90 percent. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis.

Adverse Reactions

Not all of the following reactions have been observed with every 4-aminoquinoline compound during long-term therapy, but they have been reported with one or more and should be borne in mind when drugs of this class are administered. Adverse effects with different compounds vary in type and frequency.

CNS Reactions: Irritability, nervousness, emotional changes, nightmares, psychosis, headache, dizziness, vertigo, tinnitus, nystagmus, nerve deafness, convulsions, ataxia and suicidal behavior.

Neuromuscular Reactions: Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups which may be associated with mild sensory changes, depression of tendon reflexes and abnormal nerve conduction.

Ocular Reactions:


Dermatologic Reactions: Bleaching of hair, alopecia, pruritus, skin and mucosal pigmentation, photosentivity, and skin eruptions (urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema multiforme, erythema annulare centrifugum, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and exfoliative dermatitis).

Hematologic Reactions: Various blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, anemia, thrombocytopenia (hemolysis in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency).

Gastrointestinal Reactions: Anorexia, nausea, vomiting, diarrhea, and abdominal cramps. Isolated cases of abnormal liver function and fulminant hepatic failure.

Allergic reactions: Urticaria, angioedema and bronchospasm have been reported.

Miscellaneous Reactions: Weight loss, lassitude, exacerbation or precipitation of porphyria and nonlight-sensitive psoriasis.

Cardiomyopathy has been rarely reported with high daily dosages of Dolquine.

Dosage and Administration

One tablet of Dolquine sulfate, 200 mg, is equivalent to 155 mg base.

Lupus Erythematosus

Initially, the average adult dose is 400 mg once or twice daily. This may be continued for several weeks or months, depending on the response of the patient. For prolonged maintenance therapy, a smaller dose, from 200 mg to 400 mg (=155 mg to 310 mg base) daily will frequently suffice.

The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Rheumatoid Arthritis

The compound is cumulative in action and will require several weeks to exert its beneficial therapeutic effects, whereas minor side effects may occur relatively early. Several months of therapy may be required before maximum effects can be obtained. If objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be discontinued. Safe use of the drug in the treatment of juvenile rheumatoid arthritis has not been established.

Initial dosage

In adults, from 400 mg to 600 mg (=310 mg to 465 mg base) daily, each dose to be taken with a meal or a glass of milk. In a small percentage of patients, troublesome side effects may require temporary reduction of the initial dosage. Later (usually from five to ten days), the dose may gradually be increased to the optimum response level, often without return of side effects.

Maintenance dosage

When a good response is obtained (usually in four to twelve weeks), the dosage is reduced by 50 percent and continued at a usual maintenance level of 200 mg to 400 mg (=155 mg to 310 mg base) daily, each dose to be taken with a meal or a glass of milk. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.

Should a relapse occur after medication is withdrawn, therapy may be resumed or continued on an intermittent schedule if there are no ocular contraindications.

Corticosteroids and salicylates may be used in conjunction with this compound, and they can generally be decreased gradually in dosage or eliminated after the drug has been used for several weeks. When gradual reduction of steroid dosage is indicated, it may be done by reducing every four to five days the dose of cortisone by no more than from 5 mg to 15 mg; of hydrocortisone from 5 mg to 10 mg; of prednisolone and prednisone from 1 mg to 2.5 mg; of methylprednisolone and triamcinolone from 1 mg to 2 mg; and of dexamethasone from 0.25 mg to 0.5 mg.

HOW SUPPLIED

Dolquine tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg Dolquine sulfate (equivalent to 155 mg base). Bottles of 100 tablets (NDC 0024-1562-10).

Dispense in a tight, light-resistant container as defined in the USP/NF.

Store at room temperature up to 30° C (86° F).

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

A SANOFI COMPANY

Revised April 2012

©2012 sanofi-aventis U.S. LLC

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Dolquine pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Dolquine available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Dolquine destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Dolquine Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Dolquine pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "hydroxychloroquine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "hydroxychloroquine". http://www.drugbank.ca/drugs/DB0161... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dolquine?

Depending on the reaction of the Dolquine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dolquine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Dolquine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Dolquine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dolquine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Five visitors reported frequency of use

How often in a day do you take the medicine?
Are you taking the Dolquine drug as prescribed by the doctor?

Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Dolquine is mentioned below.
Visitors%
Once in a day3
60.0%
Twice in a day2
40.0%

Five visitors reported doses

What is the dose of Dolquine drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 101-200mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
101-200mg4
80.0%
201-500mg1
20.0%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Two visitors reported age

Visitors%
> 602
100.0%

Visitor reviews


There are no reviews yet. Be the first to write one!


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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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