Remantadin

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Remantadin uses


INDICATIONS AND USAGE

Remantadin tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults.

Remantadin tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).

PROPHYLAXIS

In controlled studies of children (1 year to 16 years of age), healthy adults (17 years and older), and elderly patients (65 years of age and older), Remantadin has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Since Remantadin does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically-related viruses. Following vaccination during an influenza outbreak, Remantadin prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of Remantadin prophylaxis have not been demonstrated for longer than 6 weeks.

TREATMENT

Remantadin therapy should be considered for adults (17 years and older) who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, Remantadin has been shown to reduce the duration of fever and systemic symptoms.

The following points should be considered before initiating treatment or prophylaxis with Remantadin:

  • Remantadin is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Remantadin.
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CONTRAINDICATIONS

Remantadin is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.

PRECAUTIONS

GENERAL

An increased incidence of seizures has been reported in patients with a history of epilepsy who received the related drug amantadine. In clinical trials of Remantadin, the occurrence of seizure-like activity was observed in a small number of patients with a history of seizures who were not receiving anticonvulsant medication while taking Remantadin. If seizures develop, Remantadin should be discontinued.

The safety and pharmacokinetics of rimantadine in hepatic insufficiency have only been evaluated after single dose administration. In a study of 14 subjects with chronic liver disease, no alterations in the pharmacokinetics were observed after the administration of a single dose of rimantadine. However, the apparent clearance of rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of rimantadine and its metabolites in plasma, caution should be exercised when patients with hepatic insufficiency are treated with rimantadine.

Following multiple-dose administration of rimantadine, there were no clinically relevant differences in rimantadine systemic exposure between subjects with mild or moderate renal impairment compared to healthy subjects. In subjects with severe renal impairment, rimantadine systemic exposure increased by 81%, compared with healthy subjects. Because of the potential for increased accumulation of rimantadine metabolites in renally impaired subjects, caution should be exercised when these patients are treated with rimantadine.

Transmission of rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with rimantadine, shed rimantadine resistant virus. (Ref. 3, 4, 5, 6)

Clinical response to rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of rimantadine therapy in subjects infected with resistant virus.

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Remantadin has not been shown to prevent such complications.

DRUG INTERACTIONS

Acetaminophen

Remantadin, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, acetaminophen was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Coadministration with acetaminophen reduced the peak concentration and AUC values for rimantadine by approximately 11%.

Aspirin

Remantadin, 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, aspirin (650 mg, four times daily) was started and continued for 8 days. The pharmacokinetics of rimantadine were assessed on days 11 and 13. Peak plasma concentrations and AUC of rimantadine were reduced approximately 10% in the presence of aspirin.

Cimetidine

When a single 100 mg dose of Remantadin was administered with steady-state cimetidine, there was no statistically significant differences in rimantadine Cmax or AUC between Remantadin alone and Remantadin in the presence of cimetdine.

Live Attenuated Influenza Vaccine (LAIV)

The concurrent use of Remantadin with live attenuated intranasal influenza vaccine has not been evaluated. However, because of potential interference between these products, the live attenuated intranasal influenza vaccine should not be administered until 48 hours after cessation of Remantadin and Remantadin should be not administered until two weeks after the administration of live attenuated intranasal influenza vaccine unless medically indicated. The concern about potential interference arises principally from the potential for antiviral drugs to inhibit replication of live vaccine virus.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY

Carcinogenesis

Oral administration of rimantadine to rats for 2 years at doses up to 100 mg/kg/d [approximately 11-14 times the maximum recommended human dose based on AUC] showed no evidence of increased tumor incidence.

Mutagenesis

No mutagenic effects were seen when rimantadine was evaluated in several standard assays for mutagenicity.

Impairment of Fertility

A reproduction study in male and female rats did not show detectable impairment of fertility at dosages up to 60 mg/kg/day.

PREGNANCY

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Rimantadine is reported to cross the placenta in mice. Rimantadine has been shown to be embryotoxic in rats when given at a dose of 200 mg/kg/d. At this dose the embryotoxic effect consisted of increased fetal resorption in rats; this dose also produced a variety of maternal effects including ataxia, tremors, convulsions and significantly reduced weight gain. No embryotoxicity was observed when rabbits were given doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), but evidence of a developmental abnormality in the form of a chance in the ratio of fetuses with 12 or 13 ribs were noted. This ratio is normally about 50:50 in a litter but was 80:20 after rimantadine treatment. However, in a repeat embryofetal toxicity study in rabbits at doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), this abnormality was not observed.

Nonteratogenic Effects

Rimantadine was administered to pregnant rats in a peri- and postnatal reproduction toxicity study at doses of 30, 60 and 120 mg/kg/d (1.7, 3.4 and 6.8 times the MRHD based on mg/m2). Maternal toxicity during gestation was noted at the two higher doses of rimantadine, and at the highest dose, 120 mg/kg/day, there was an increase in pup mortality during the first 2 to 4 days postpartum. Decreased fertility of the F1 generation was also noted for the two higher doses.

For these reasons, Remantadin should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

NURSING MOTHERS

Remantadin should not be administered to nursing mothers because of the adverse effects noted in offspring of rats treated with rimantadine during the nursing period. Rimantadine is concentrated in rat milk in a dose-related manner: 2 to 3 hours following administration of rimantadine, rat breast milk levels were approximately twice those observed in the serum.

PEDIATRIC USE

In children (1 year to 16 years of age), Remantadin is recommended for the prophylaxis of influenza A. The safety and effectiveness of Remantadin in the treatment of symptomatic influenza infection in children (1 year to 16 years of age) have not been established. Prophylaxis studies with Remantadin have not been performed in children below the age of 1 year.

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ADVERSE REACTIONS

In 1,027 patients treated with Remantadin in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.

Incidence >1%: Adverse events reported most frequently (1-3%) at the recommended dose in controlled clinical trials are shown in the table below.

Rimantadine

(n=1027)

Control

(n=986)

Nervous System
Insomnia 2.1% 0.9%
Dizziness 1.9% 1.1%
Headache 1.4% 1.3%
Nervousness 1.3% 0.6%
Fatigue 1.0% 0.9%
Gastrointestinal System
Nausea 2.8% 1.6%
Vomiting 1.7% 0.6%
Anorexia 1.6% 0.8%
Dry mouth 1.5% 0.6%
Abdominal Pain 1.4% 0.8%
Body as a Whole
Asthenia 1.4% 0.5%

Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea.

Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia.

Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Remantadin. In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.

Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence >1%.

Rimantadine

200 mg/day

(n=145)

Placebo

(n=143)

Amantadine

200 mg/day

(n=148)

Nervous System
Insomia 3.4% 0.7% 7.0%
Nervousness 2.1% 0.7% 2.8%
Impaired

Concentration


2.1%


1.4%


2.1%

Dizziness 0.7% 0.0% 2.1%
Depression 0.7% 0.7% 3.5%
Total % of subjects of adverse reactions

6.9%


4.1%


14.7%

Total % of subjects withdrawn due to adverse reactions

6.9%


3.4%`


14.0%

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GERIATRIC USE

Approximately 200 patients over the age of 64 were evaluated for safety in controlled clinical trials with Remantadin. Geriatric subjects who received either 200 mg or 400 mg of rimantadine daily for 1 to 50 days experienced considerably more central nervous system and gastrointestinal adverse events than comparable geriatric subjects receiving placebo. Central nervous system events including dizziness, headache, anxiety, asthenia, and fatigue, occurred up to two times more often in subjects treated with rimantadine than in those treated with placebo. Gastrointestinal symptoms, particularly nausea, vomiting, and abdominal pain occurred at least twice as frequently in subjects receiving rimantadine than in those receiving placebo. The gastrointestinal symptoms appeared to be dose related. In patients over 65, the recommended dose is 100 mg, daily (see CLINCAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).

OVERDOSAGE

As with any overdose, supportive therapy should be administered as indicated. Overdoses of a related drug, amantadine, have been reported with adverse reactions consisting of agitation, hallucinations, cardiac arrhythmia and death. The administration of intravenous physostigmine (a cholinergic agent) at doses of 1 to 2 mg in adults (Ref. 7) and 0.5 mg in children (Ref. 8) repeated as needed as long as the dose did not exceed 2 mg/hour has been reported anecdotally to be beneficial in patients with central nervous system effects from overdoses of amantadine.

DOSAGE AND ADMINISTRATION

FOR PROPHYLAXIS IN ADULTS AND CHILDREN

Adults

The recommended adult dose of Remantadin is 100 mg twice a day. Study durations ranged from 11 days to 6 weeks in adult and elderly patients. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and in elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects.

Children

  • Study duration ranged from 5 weeks to 6 weeks in pediatric subjects.
  • In children 1 year to 9 years of age, Remantadin should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg.
  • For children 10 years of age or older, use the adult dose.

(see Directions for Compounding of an Oral Suspension from Remantadin Tablets to prepare an oral suspension for administration to children and patients with difficulty swallowing tablets).

Children

The safety and efficacy of Remantadin for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established.

FOR TREATMENT IN ADULTS

Adults

The recommended adult dose of Remantadin is 100 mg twice a day for 7 days. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects. Remantadin therapy should be initiated as soon as possible, preferably within 48 hours after onset of signs and symptoms of influenza A infection. Therapy should be continued for approximately seven days from the initial onset of symptoms.

Children

Remantadin is not indicated for treatment of influenza in pediatric patients 16 years or younger.

Directions for the Compounding of an Oral Suspension from Remantadin Tablets 1

These directions are provided for use only during emergency situations, for patients who have difficulty swallowing tablets or where lower doses are needed. The pharmacist may compound a suspension (10 mg/mL) from Remantadin tablets, 100 mg using Ora-Sweet®.Ora-Sweet® is a registered trademark of Paddock Laboratories Other vehicles have not been studied.

To make an oral suspension (10 mg/mL) from 100 mg Remantadin tablets, you will need the following:

  • 100 mg tablets of Remantadin
  • Ora-Sweet® (a vehicle manufactured by Paddock Laboratories)
  • a graduated cylinder
  • a mortar and pestle
  • an Amber Glass or Polyethylene terephthalate plastic (PET) bottle
  • a funnel (optional)

Compounding Procedures

A 100 mg tablet of Remantadin is required for each 10 mL of compounded oral suspension to make a concentration of 10 mg/mL.

A compounded oral suspension is stable for 14 days. Therefore, the maximum amount of oral suspension that can be dispensed to a patient should not exceed a 14 day supply.

Step A: Guidance for how to determine the Number of Tablets and Total Volume needed to compound a 10 mg/mL oral suspension for each patient

  • Verify the prescribed dose is correct.
  • Calculate the mg amount of Remantadin needed for the duration of therapy.

    × (Number of days) = (mg of Remantadin)

    For example, 75 mg/day × 10 days = 750 mg

  • Round up the mg of Remantadin amount to the next 100 mg designation.

    For example, Round up 750 mg to 800 mg

  • Calculate the Number of 100 mg tablets that are required for the compounded oral suspension.

    (Rounded mg of Remantadin) ÷ (100 mg/tablet) = (Number of tablets)

    For example, 800 mg ÷100 mg/tablet = 8 tablets

  • Calculate the Total Volume of compounded oral suspension (10 mg/mL) (Rounded mg of Remantadin) ÷ (10 mg/mL) = (Total Volume)

    For example, 800 mg ÷ 10 mg/mL = 80 mL


Step B: Once the total Number of Tablets and Volume are determined then follow the procedures below for compounding the oral suspension (10 mg/mL) from Remantadin tablets 100 mg

Verify your calculations before you begin to compound an oral suspension.

A 100 mg tablet of Remantadin is required for each 10 mL's of compounded oral suspension to make a concentration of 10 mg/mL.

  • Place the required number of Remantadin 100 mg tablets into a clean mortar of sufficient size to contain the tablets and volume of vehicle, Ora-Sweet® used in Step 3.
  • Grind the tablets and triturate to a fine powder using a pestle. Powder on the sides of the mortar or pestle should be removed using a spatula and incorporated into the trituration throughout the process.
  • Slowly add approximately one-third (1/3) of the total volume of vehicle to the mortar while triturating until a uniform suspension is achieved.
  • Transfer the suspension to an amber glass or a PET plastic bottle. Other types of bottles, such as non-PET plastic or uncolored bottles, have not been evaluated and should not be used. A funnel may be used to eliminate any spillage.
  • Slowly add the second one-third (1/3) of the total volume of vehicle to the mortar, rinse the pestle and mortar by a triturating motion and transfer the contents into the bottle.
  • Repeat the rinsing (Step 5) with the remaining one-third (1/3) of the vehicle, transferring the remaining contents to the fullest extent possible. Verify that the suspension is at the desired total volume or add additional vehicle if needed.
  • Close the bottle using a child-resistant cap.
  • Shake well to ensure homogeneous suspension. (Note: The active drug, rimantadine HCl readily dissolves in the specified vehicle. The suspension is caused by some of the inert ingredients of Remantadin tablets 100 mg which are insoluble in this vehicle.)
  • Include an ancillary label on the bottle indicating "Shake Gently Before Use." This compounded suspension should be gently shaken prior to administration to minimize the tendency for air entrapment with the Ora-Sweet® preparation. The need to shake the compounded oral suspension gently prior to administration should be reviewed with the parent or guardian when the suspension is dispensed.
  • Provide an oral dosing device (a graduated oral syringe or spoon) that will measure the prescribed dose (in mL). If possible, mark or highlight the graduation corresponding to the appropriate dose on the oral syringe or spoon for each patient.
  • Include an Expiration Date label according to storage condition and a "Discard any Unused Portion" label to the bottle. Instruct the parent or guardian that any remaining material following completion of therapy or after the expiration date on the label must be discarded.

STORAGE OF THE PHARMACY-COMPOUNDED SUSPENSION

Room Temperature: Stable for 14 days when stored in ambient room temperature conditions. Other storage conditions have not been studied.

Note: The storage conditions are based on stability studies of compounded oral suspensions, using the above mentioned vehicle, which was placed in amber glass and PET plastic bottles at 25°C (77°F). Stability studies have not been conducted with other vehicles or bottle types.

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HOW SUPPLIED

Remantadin Tablets, 100 mg-Each orange, oval, film-coated, convex-faced tablet is debossed with a "G" on one side and "1911" on the other side.

Bottles of 100 NDC 0115-1911-01
Bottles of 500 NDC 0115-1911-02

Store at 20°C to 25°C (68° to 77°F)

REFERENCES

  • Belshe RB, Burk B, Newman F, et al. J. Infect. Dis. 1989; 159(3):430-435.
  • Sim IS, Cerruti RL, Connell EV. J. Resp. Dis. 1989(Suppl): S46-S51.
  • Hayden FG, Belshe RB, Clover RD, et al. N.Engl. J. Med. 1989; 321(25), 1696-1702.
  • Hall CB, Dolin R, Gala CL, et al. Pediatrics 1987; 80(2): 275-282.
  • Thompson J, Fleet W, Lawrence E et al. J.Med. Virol. 1987; 21(3): 249-255.
  • Belshe RB, Smith MH, Hall CB, et al. J. Virol.1988; 62(5): 1508-1512.
  • Casey DE. N Engl J Med. 1978; 298(9):516.
  • Berkowitz CD. J. Pediatri. 1979; 95(1): 144-145.
  • Hayden FG, Sperber SJ, Belshe RB, et al. Antimicrob Agents Chemother. 1991; 35(9): 1741-1747
  • Deyde VM, Xu X, Bright RA, et al. J Infect Dis. 2007; 196(2): 249-257.
  • CDC MMWR Morb Mortal Wkly Rep. 2009; 58(16): 433-435.

Dist. by:

Global Pharmaceuticals

Division of IMPAX Laboratories, Inc.

Philadelphia, PA 19124 USA

Rev. 04/2010

224-03

Rimantadine 100mg Tablet

Chemical Structure

Remantadin 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.


Remantadin 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.


Remantadin 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.


Remantadin 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.


Remantadin 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."RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "rimantadine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "rimantadine". http://www.drugbank.ca/drugs/DB0047... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Remantadin?

Depending on the reaction of the Remantadin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Remantadin 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 Remantadin 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 Remantadin, 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 Remantadin 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.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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