Ingredients Active Ingredients: 500 mg of chloroquine phosphate USP, equivalent to 300 mg chloroquine base.

Non-Active Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide

 

Indications
The main use of Aralen is to prevent and treat malaria; in addition it has shown to be very effective against arthritis and a variety of other conditions. Aralen is indicated for the suppressive treatment and for acute attacks of malaria due to P. vivax, P.malariae, P. ovale, and susceptible strains of P. falciparum. Aralen can also treat extraintestinal amebiasis. It can also be used as treatment for arthritis in children and people with high levels of calcium in the blood associated with sarcoidosis, rheumatoid arthritis, systematic Lupus erythematosus and various skin disorders.

How It Works
This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in other body tissues. Both drugs may be needed for a complete cure and to prevent the return of infection (relapse). The malarial parasite must degrade hemoglobin in the blood so that it can acquire essential amino acids, which the parasite requires to construct its own protein and for energy metabolism. Digestion is carried out in a vacuole of the parasite cell. Aralen enters the red blood cells, inhabits the parasite cell through diffusion. Chloroquine binds to heme to form FP-Chloroquine, a highly toxic substance to the cell disrupting its membrane function killing the parasitic cell.

Dosage
Tablets (250 mg, 500 mg)
For ruhmatoid arthritis:
Initial and maintenance is 250 mg daily.
For malaria suppression:
Adult Dose is 500 mg (300 mg base) on exactly the same day of each week.
Children’s Dose is 5 mg of active base, per kg of body weight, should in no case exceed the adult dose regardless of weight.

For treatment of acute attack:
Adult Dose: An initial dose of 1 g (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.
The dosage for adults of low body weight and children should be determined as follows:
First dose: 10 mg base per kg (not exceeding adult dose)
Second dose: (6 hours after first dose) 5 mg base per kg (not exceeding 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.
For radical cure of vivax and malariae malaria concomitant therapy an 8-aminoquinoline compound is necessary.

For treatment of extraintestinal amebiasis:
In adults 1 g. (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.

Take this medication with food to prevent stomach upset. Take this medication exactly as prescribed. It is important to continue treatment for the length of time prescribed. Stopping therapy too soon may not treat the infection and can lead to re-infection. While taking this medication, your doctor may schedule lab tests to check your eyesight, hearing and blood.

Should you be taking Aralen for other medical conditions consult with a doctor to ensure it is the right medication for your particular condition. Dosage information does not exist for all conditions. Most arthritis conditions recommend one 250mg tablet once per day, but consultation with a medical professional is sincerely recommended.
 

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Precautions
Consult a doctor before taking Aralen, especially if you are pregnant or breastfeeding. There are dangers to unborn infants as well as infants being breastfed. A qualified physician must carefully weight benefits of taking this medication against possible risks.
Certain strains of P. falciparum have been resistant to 4-aminoquioline compounds (including chloroquine and hydroxychloroquine).
Before using chloroquine for prophylaxis, it should be ascertained whether chloroquine is appropriate for use in region visited by travelers
Patients infected with a resistant strain of plasmodia a should be treated with another form of antimalaria therapy.
Irreversible retinal damage has been observed in some patients Aralan does not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms of the parasite, nor will it prevent vivax or malariae infection when administered as a prophylactic. It is highly effective as a suppressive agent in patients with vivax or malariae malaria, in terminating acute attacks, and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum. This medicine must be taken regularly as ordered by your doctor in order for it to help you. It may take up to several weeks before you begin to feel better. It may take up to 6 months before you feel the full benefit of this medicine. If your symptoms of arthritis do not improve within a few weeks or months check immediately with your doctor.
If taking Aralen for other medical conditions consult with a doctor to ensure it is the right medication for your particular condition.
A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses in children. Parents should be diligent and keep out of the reach of children. Aralen in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria  the condition may be exacerbated. The drug should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the potential risks.

Drug Interactions
Consult a doctor before taking Aralen if you are taking:
Antacids and kaolin: Antacids and kaolin can reduce absorption of chloroquine.
Cimetidine: Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level.
Ampicillin: In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin.
Cyclosporine: After introduction of chloroquine (oral form), a sudden increase in serum cyclosporine level has been reported. Therefore, close monitoring of serum cyclosporine level is recommended and, if necessary, chloroquine should be discontinued.
In addition speak to your doctor is you are currently on other medication: Aurothioglucose, Bepridil, Cisapride, Levomethadyl, Mesoridazine, Pimozide, Terfenadine, Thioridazine, or Ziprasidone

Adverse/Side Effects
Possible side effects include: nausea, vomiting, stomach upset, cramps, loss of appetite, diarrhea, tiredness, weakness or headache may occur the first several days as your body adjusts to the medication. If these effects continue or become bothersome, inform your doctor. Tell your doctor immediately if any of these serious side effects occur: blurred vision, trouble seeing at night or problems focusing clearly, ringing in the ears, difficulty hearing. Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, mental/mood changes. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, irregular heartbeat, persistent sore throat or fever, easy bleeding or bruising. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist. If a woman is pregnant their may exist a risk to the unborn infant, if anti-malaria medication is necessary consultation with a physician is recommended as the risks must be weighted against the benefits.

 

Overdose
Chloroquine is very rapidly and completely absorbed after ingestion. Toxic doses of chloroquine can be fatal. If you suspect overdose, contact your local poison control center or emergency room immediately! As little as 1 g may be fatal in children. Toxic symptoms can occur within minutes. These consist of headache, drowsiness, visual disturbances, nausea and vomiting, cardiovascular collapse, shock and convulsions followed by sudden and early respiratory and cardiac arrest. The electrocardiogram may reveal atrial standstill, nodal rhythm, prolonged intraventricular conduction time, and progressive bradycardia leading to ventricular fibrillation and/or arrest. 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 stomach tube, after lavage, and within 30 minutes after ingestion of the antimalarial, 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 chloroquine ingested. Convulsions should be controlled before attempting gastric lavage. If due to cerebral stimulation, cautious administration of an ultra short-acting barbiturate may be tried but, if due to anoxia, it should be corrected by oxygen administration and artificial respiration. Monitor ECG. In shock with hypotension, a potent vasopressor should be administered. Replace fluids and electrolytes as needed. Cardiac compressing or pacing may be indicated to sustain the circulation. Because of the importance of supporting respiration, tracheal intubation or tracheostomy, followed by gastric lavage, may also be necessary.

Storage Instructions
Store at room temperature, away from moisture and light, and out of reach of children and pets.

 

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