DRUGS & SUPPLEMENTS

Spasmo-Urgenin

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Spasmo-Urgenin uses

Spasmo-Urgenin consists of Echinacea Angustifolia, Saw Palmetto, Trospium Chloride.

Echinacea Angustifolia:



Echinacea Sp.

Active Ingredients:

Echinacea [Echinacea angustifolia] 7.5mg per ml

Echinacea [Echinacea pallida] 7.5mg per ml

Inactive Ingredients:

Acetic acid glacial and Propionic acid [organic preservatives[Salt,Water

FOR USE ON ANIMALS ONLY

Immuzim contains NO animal parts or residues

Imported to the USA by :

Emerald Valley Natural Health Inc, Exeter, NH 03833

Batch No: 94414

Use by Date: 03/12/11

Immuzim is manufactured in the UK by

SCA Nutec [Provimi Ltd]

Nutec Mill, Eastern Avenue

Lichfield, Staffordshire, WS13 7SE, UK

Exported by :

Equiglobal Ltd

Manningtree, Essex, CO11 1UT, UK

20 Litres/5.283 gallons [US]

image of container

Trospium Chloride:


1 INDICATIONS AND USAGE

Spasmo-Urgenin (Trospium Chloride) tablets USP are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Spasmo-Urgenin (Trospium Chloride) tablets USP are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)

2 DOSAGE AND ADMINISTRATION

The recommended dose is 20 mg twice daily. Spasmo-Urgenin (Trospium Chloride) tablets USP should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:

  • For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
  • In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [see Use in Specific Populations (8.5)].
  • The recommended dose of Spasmo-Urgenin (Trospium Chloride) tablets USP is one 20 mg tablet twice daily. Spasmo-Urgenin (Trospium Chloride) tablets USP should be dosed with water on an empty stomach, at least one hour before a meal. (2)
  • For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime. (2)
  • In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability. (2)
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3 DOSAGE FORMS AND STRENGTHS

Spasmo-Urgenin (Trospium Chloride) tablets USP are supplied as 20 mg tablets (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on other side).

  • 20 mg tablets. (3)

4 CONTRAINDICATIONS

Spasmo-Urgenin (Trospium Chloride)is contraindicated in patients with:

  • urinary retention
  • gastric retention
  • uncontrolled narrow-angle glaucoma.
  • known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported.

Spasmo-Urgenin (Trospium Chloride) is contraindicated in

  • patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions (4)
  • patients with known hypersensitivity (4)

5 WARNINGS AND PRECAUTIONS

  • Spasmo-Urgenin should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. (5.1, 5.3)
  • Angioedema of the face, lips, tongue and/or larynx has been reported with Spasmo-Urgenin (Trospium Chloride). (5.2)
  • In patients with controlled narrow angle glaucoma Spasmo-Urgenin (Trospium Chloride) should be used only with careful monitoring. (5.4)
  • Central Nervous System Effects: Somnolence has been reported with Spasmo-Urgenin (Trospium Chloride). Advise patients not to drive or operate heavy machinery until they know how Spasmo-Urgenin (Trospium Chloride) affects them (5.5).
  • Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, the risk of anticholinergic adverse reactions is expected to be greater in patients with moderate renal impairment. (5.6)

5.1 Risk of Urinary Retention

Spasmo-Urgenin (Trospium Chloride) should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4)].

5.2 Angioedema

Angioedema of the face, lips, tongue, and/or larynx has been reported with Spasmo-Urgenin, the active ingredient in Spasmo-Urgenin (Trospium Chloride). In one case, angioedema occurred after the first dose of Spasmo-Urgenin (Trospium Chloride). Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, Spasmo-Urgenin (Trospium Chloride) should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.3 Decreased Gastrointestinal Motility

Spasmo-Urgenin (Trospium Chloride) should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4)]. Spasmo-Urgenin (Trospium Chloride), like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

5.4 Controlled Narrow-angle Glaucoma

In patients being treated for narrow-angle glaucoma, Spasmo-Urgenin should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring [see Contraindications (4)].

5.5 Central Nervous System Effects

Spasmo-Urgenin (Trospium Chloride) is associated with anticholinergic central nervous system (CNS) effects . A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Spasmo-Urgenin (Trospium Chloride) affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6 Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment

Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment [see Dosage and Administration (2), and Use in Specific Populations (8.6)].

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6 ADVERSE REACTIONS

The most common adverse reactions with Spasmo-Urgenin (Trospium Chloride) are dry mouth (20.1%), constipation (9.6%), and headache (4.2%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1(888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Spasmo-Urgenin (Trospium Chloride) was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with Spasmo-Urgenin (Trospium Chloride) (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received Spasmo-Urgenin (Trospium Chloride) tablets 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Spasmo-Urgenin (Trospium Chloride) for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving Spasmo-Urgenin (Trospium Chloride) tablets 20 mg twice daily and 1.5% among patients receiving placebo. Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the Spasmo-Urgenin (Trospium Chloride) group than in the placebo group.

The two most common adverse reactions reported by patients receiving Spasmo-Urgenin (Trospium Chloride) tablets 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for Spasmo-Urgenin (Trospium Chloride), dry mouth, occurred in 20.1% of Spasmo-Urgenin (Trospium Chloride) treated patients and 5.8% of patients receiving placebo. In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with Spasmo-Urgenin (Trospium Chloride) tablets 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

Table 1. Incidence (%) of adverse reactions with Spasmo-Urgenin (Trospium Chloride), reported in greater than or equal to 1% of all patients treated with Spasmo-Urgenin (Trospium Chloride) and more frequent with Spasmo-Urgenin (Trospium Chloride) tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined


Adverse Reaction


Placebo

(N=590)


Spasmo-Urgenin (Trospium Chloride) Tablets 20 mg

twice daily

(N=591)


Gastrointestinal Disorders


Dry mouth


34 ( 5.8)


119 (20.1)


Constipation


27 (4.6)


57 (9.6)


Abdominal pain upper


7 (1.2)


9 (1.5)


Constipation aggravated


5 (0.8)


8 (1.4)


Dyspepsia


2 (0.3)


7 (1.2)


Flatulence


5 (0.8)


7 (1.2)


Nervous System Disorders


Headache


12 (2.0)


25 (4.2)


General Disorders


Fatigue


8 (1.4)


11 (1.9)


Renal and Urinary Disorders


Urinary retention


2 (0.3)


7 (1.2)


Eye Disorders


Dry eyes


2 (0.3)


7 (1.2)


Other adverse reactions from the U.S., placebo-controlled trials, occurring in greater than or equal to 0.5% and less than 1.0% of Spasmo-Urgenin (Trospium Chloride) treated patients, and more common with Spasmo-Urgenin (Trospium Chloride) than placebo are: tachycardia, vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Spasmo-Urgenin (Trospium Chloride). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, “hypertensive crisis”; Immunological – Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – dizziness, confusion, vision abnormal, hallucinations, somnolence and delirium; Musculoskeletal – rhabdomyolysis; General – rash.

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7 DRUG INTERACTIONS

  • Concomitant use with digoxin did not affect the pharmacokinetics of either drug.
  • Some drugs which are actively secreted by the kidney may interact with Spasmo-Urgenin (Trospium Chloride) by competing for renal tubular secretion. (7.2)
  • Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. (7.4)

7.1 Digoxin

Concomitant use of Spasmo-Urgenin (Trospium Chloride) and digoxin did not affect the pharmacokinetics of either drug [see Clinical Pharmacology (12.3)].

7.2 Drugs Eliminated by Active Tubular Secretion

Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, Spasmo-Urgenin has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of Spasmo-Urgenin (Trospium Chloride) with these drugs may increase the serum concentration of Spasmo-Urgenin (Trospium Chloride) and/or the coadministered drug due to competition for this elimination pathway. Careful patient monitoring is recommended in patients receiving such drugs [see Clinical Pharmacology (12.3)].

7.3 Antimuscarinic Agents

The concomitant use of Spasmo-Urgenin (Trospium Chloride) with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Spasmo-Urgenin (Trospium Chloride) may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

7.4 Metformin

Co-administration of 500 mg metformin immediate release tablets twice daily with Spasmo-Urgenin (Trospium Chloride) 60 mg extended release reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax [see Clinical Pharmacology (12.3)].

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8 USE IN SPECIFIC POPULATIONS

  • The safety and effectiveness of Spasmo-Urgenin in pediatric patients have not been established. (8.4)

8.1 Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies of Spasmo-Urgenin in pregnant women. Spasmo-Urgenin (Trospium Chloride) should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Spasmo-Urgenin (Trospium Chloride) treatment are encouraged to contact their physician.

Risk Summary

Based on animal data, Spasmo-Urgenin (Trospium Chloride) is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

Animal Data

In a rat embryo/fetal development study, pregnant rats received doses of Spasmo-Urgenin up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the MRHD of 40 mg, based on AUC. No malformations or fetal toxicity were observed.

The offspring of female rats exposed orally, pre-and post-natally, to Spasmo-Urgenin (Trospium Chloride) up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups. However, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. A no-effect level for maternal and pup toxicity (survival to Day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

In a rabbit embryo/fetal development study, pregnant rabbits received doses of Spasmo-Urgenin (Trospium Chloride) up to 200 mg/kg/day, from implantation to closure of the fetal hard palate. At 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the MRHD of 40 mg, based on AUC. However, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day.

8.2 Labor and Delivery

The effect of Spasmo-Urgenin (Trospium Chloride) tablets on labor and delivery is unknown.

8.3 Nursing Mothers

Spasmo-Urgenin (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Spasmo-Urgenin (Trospium Chloride) should be used during lactation only if the potential benefit justifies the potential risk to the newborn.

8.4 Pediatric Use

The safety and effectiveness of Spasmo-Urgenin (Trospium Chloride) in pediatric patients have not been established.

8.5 Geriatric Use

Of the 591 patients with overactive bladder who received treatment with Spasmo-Urgenin in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight Spasmo-Urgenin (Trospium Chloride) treated patients (15%) were greater than or equal to 75 years of age.

In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with Spasmo-Urgenin (Trospium Chloride) (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients. This effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [see Clinical Pharmacology (12.3)]. Therefore, based upon tolerability, the dose frequency of Spasmo-Urgenin (Trospium Chloride) may be reduced to 20 mg once daily in patients 75 years of age and older.

8.6 Renal Impairment

Severe renal impairment (creatinine clearance less than 30 mL/minute) significantly altered the disposition of Spasmo-Urgenin (Trospium Chloride). A 4.2-fold and 1.8-fold increase in mean AUC(0-∞) and Cmax, respectively, and the appearance of an additional elimination phase with a long half-life (~33 hr) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 mL/min. The different pharmacokinetic behavior of Spasmo-Urgenin (Trospium Chloride) in patients with severe renal impairment necessitates adjustment of dosage frequency [see Dosage and Administration (2)]. The pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30-80 mL/min.

Trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

8.7 Hepatic Impairment

There is no information regarding the effect of severe hepatic impairment on exposure to Spasmo-Urgenin (Trospium Chloride). In a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release Spasmo-Urgenin (Trospium Chloride), mean Cmax increased 12% and 63%, respectively, and mean AUC(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. The clinical significance of these findings is unknown. Caution should be used when administering Spasmo-Urgenin (Trospium Chloride) to patients with moderate and severe hepatic impairment.

10 Overdosage

Overdosage with antimuscarinic agents, including Spasmo-Urgenin (Trospium Chloride), can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, electrocardiographic monitoring is recommended.

A 7-month-old baby experienced tachycardia and mydriasis after administration of a single dose of trospium 10 mg given by a sibling. The baby’s weight was reported as 5 kg. Following admission into the hospital and about 1 hour after ingestion of the trospium, medicinal charcoal was administered for detoxification. While hospitalized, the baby experienced mydriasis and tachycardia up to 230 beats per minute. Therapeutic intervention was not deemed necessary. The baby was discharged as completely recovered the following day.

11 DESCRIPTION

Spasmo-Urgenin (Trospium Chloride) USP is a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of Spasmo-Urgenin (Trospium Chloride) USP is C25H30ClNO3 and its molecular weight is 427.97. The structural formula of Spasmo-Urgenin (Trospium Chloride) USP is represented below:

Spasmo-Urgenin (Trospium Chloride) USP is a white or almost white, crystalline powder. It is soluble in water, freely soluble in methanol, practically insoluble in methylene chloride.

Each Spasmo-Urgenin (Trospium Chloride)tablet USP contains 20 mg of Spasmo-Urgenin (Trospium Chloride) USP, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, sucrose, copovidone, titanium dioxide, polyethylene glycol 6000, talc, hypromellose, macrogol, yellow iron oxide, red iron oxide.

Spasmo-Urgenin (Trospium Chloride) structural formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Spasmo-Urgenin is a muscarinic antagonist.

Spasmo-Urgenin (Trospium Chloride) antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.

Receptor assays showed that Spasmo-Urgenin (Trospium Chloride) has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.

12.2 Pharmacodynamics

Placebo-controlled studies employing urodynamic variables were conducted in patients with conditions characterized by involuntary detrusor contractions. The results demonstrate that Spasmo-Urgenin (Trospium Chloride)increases maximum cystometric bladder capacity and volume at first detrusor contraction.

Electrophysiology

The effect of 20 mg twice daily and up to 100 mg twice daily Spasmo-Urgenin on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg once daily) controlled 5 day parallel trial in 170 male and female healthy volunteer subjects aged 18 to 45 years. The QT interval was measured over a 24-hour period at steady state. The 100 mg twice daily dose of Spasmo-Urgenin (Trospium Chloride) was chosen because this achieves the Cmax expected in severe renal impairment. Spasmo-Urgenin (Trospium Chloride) was not associated with an increase in individual corrected (QTcI) or Fridericia corrected (QTcF) QT interval at any time during steady state measurement, while moxifloxacin was associated with a 6.4 msec increase in QTcF.

In this study, asymptomatic, non-specific T wave inversions were observed more often in subjects receiving Spasmo-Urgenin (Trospium Chloride) than in subjects receiving moxifloxacin or placebo following five days of treatment. This finding was not observed during routine safety monitoring in 2 other placebo-controlled clinical trials in 591 Spasmo-Urgenin (Trospium Chloride) treated overactive bladder patients [see Clinical Studies (14)]. The clinical significance of T wave inversion in this study is unknown. Spasmo-Urgenin (Trospium Chloride) is associated with an increase in heart rate that correlates with increasing plasma concentrations. In the study described above, Spasmo-Urgenin (Trospium Chloride) demonstrated a mean increase in heart rate compared to placebo of 9.1 bpm for the 20 mg dose and of 18 bpm for the 100 mg dose. In the two U.S. placebo-controlled trials in patients with overactive bladder, the mean increase in heart rate compared to placebo in Study 1 was observed to be 3 bpm and in Study 2 was 4 bpm.

12.3 Pharmacokinetics

Absorption:

After oral administration, less than 10% of the dose is absorbed. Mean absolute bioavailability of a 20 mg dose is 9.6%. Peak plasma concentrations (Cmax) occur between 5 to 6 hours post-dose. Mean Cmax increases greater than dose-proportionally; a 3-fold and 4-fold increase in Cmax was observed for dose increases from 20 mg to 40 mg and from 20 mg to 60 mg, respectively. AUC exhibits dose linearity for single doses up to 60 mg. Spasmo-Urgenin (Trospium Chloride) exhibits diurnal variability in exposure with a decrease in Cmax and AUC of up to 59% and 33%, respectively, for evening relative to morning doses.

Effect of Food:

Administration with a high (50%) fat-content meal resulted in reduced absorption, with AUC and Cmax values 70-80% lower than those obtained when Spasmo-Urgenin (Trospium Chloride) was administered while fasting. Therefore, it is recommended that Spasmo-Urgenin (Trospium Chloride)should be taken at least one hour prior to meals or on an empty stomach [see Dosage and Administration (2)].

A summary of mean (± standard deviation) pharmacokinetic parameters for a single 20 mg dose of Spasmo-Urgenin (Trospium Chloride) tablets is provided in Table 2.

Table 2. Mean (± SD) Pharmacokinetic Parameter Estimates for a Single 20 mg Spasmo-Urgenin (Trospium Chloride) Tablet Dose in Healthy Volunteers


Cmax


AUC0-∞


Tmax


t½


(ng/mL)


(ng/mL-hr)


(hr)


(hr)


3.5 ± 4.0


36.4 ± 21.8


5.3 ± 1.2


18.3 ± 3.2


The mean plasma concentration-time (+ SD) profile for Spasmo-Urgenin (Trospium Chloride) is shown in Figure 1.

Figure 1 -Mean (+ SD) Concentration-Time Profile for a Single 20 mg Oral Dose of Spasmo-Urgenin (Trospium Chloride) Tablets in Healthy Volunteers

Figure 1 -Mean (+ SD) Concentration-Time Profile for a Single 20 mg Oral Dose of Spasmo-Urgenin (Trospium Chloride) Tablets in Healthy Volunteers

Distribution:

Protein binding ranged from 50 to 85% when concentration levels of Spasmo-Urgenin (0.5-50 ng/mL) were incubated with human serum in vitro.

The 3H-trospium chloride ratio of plasma to whole blood was 1.6:1. This ratio indicates that the majority of 3H-trospium chloride is distributed in plasma.

The apparent volume of distribution for a 20 mg oral dose is 395 (± 140) liters.

Metabolism:

The metabolic pathway of trospium in humans has not been fully defined. Of the 10% of the dose absorbed, metabolites account for approximately 40% of the excreted dose following oral administration. The major metabolic pathway is hypothesized as ester hydrolysis with subsequent conjugation of benzylic acid to form azoniaspironortropanol with glucuronic acid. Cytochrome P450 (CYP) is not expected to contribute significantly to the elimination of trospium. Data taken from in vitro human liver microsomes investigating the inhibitory effect of trospium on seven CYP isoenzyme substrates (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4) suggest a lack of inhibition at clinically relevant concentrations.

Excretion:

The plasma half-life for Spasmo-Urgenin following oral administration is approximately 20 hours. After oral administration of an immediate-release formulation of 14C-trospium chloride, the majority of the dose (85.2%) was recovered in feces and a smaller amount (5.8% of the dose) was recovered in urine; 60% of the radioactivity excreted in urine was unchanged trospium.

The mean renal clearance for trospium (29.07 L/hour) is 4-fold higher than average glomerular filtration rate, indicating that active tubular secretion is a major route of elimination for trospium. There may be competition for elimination with other compounds that are also renally eliminated [see Drug Interactions (7.2)].

Drug Interactions

Digoxin: Concomitant use of 20 mg Spasmo-Urgenin (Trospium Chloride) immediate release twice daily at steady state and a single dose of 0.5 mg digoxin in a crossover study with 40 male and female subjects did not affect the pharmacokinetics of either drug.

Metformin: A drug interaction study was conducted in which Spasmo-Urgenin (Trospium Chloride) extended release 60 mg once daily was coadministered with Glucophage ® (metformin hydrochloride) 500 mg twice daily under steady-state conditions in 44 healthy subjects. Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax. The effect of decrease in trospium exposure on the efficacy of Spasmo-Urgenin (Trospium Chloride) extended release is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg Spasmo-Urgenin (Trospium Chloride) extended release once daily under fasted condition. The effect of metformin at higher doses on trospium PK is unknown.

Specific Populations

Age : Age did not appear to significantly affect the pharmacokinetics of Spasmo-Urgenin (Trospium Chloride), however, increased anticholinergic side effects unrelated to drug exposure were observed in patients greater than or equal to 75 years of age [see Use in Specific Populations (8.5)].

Pediatric : The pharmacokinetics of Spasmo-Urgenin (Trospium Chloride) were not evaluated in pediatric patients.

Race : Pharmacokinetic differences due to race have not been studied.

Gender : Studies comparing the pharmacokinetics in different genders had conflicting results. When a single 40 mg Spasmo-Urgenin (Trospium Chloride) tablets dose was administered to 16 elderly subjects, exposure was 45% lower in elderly females compared to elderly males. When 20 mg Spasmo-Urgenin (Trospium Chloride) tablets was dosed twice daily for 4 days to 6 elderly males and 6 elderly females (60 to 75 years), AUC and Cmax were 26% and 68% higher, respectively, in females without hormone replacement therapy than in males.

Renal Impairment: In a clinical pharmacokinetic study where a single dose of 40 mg immediate release Spasmo-Urgenin (Trospium Chloride) was administered to 12 healthy males and 12 males with severe renal impairment, severe renal impairment (creatinine clearance less than 30 mL/minute) significantly altered the disposition of Spasmo-Urgenin (Trospium Chloride). A 4.2-fold and 1.8-fold increase in mean AUC(0-∞) and Cmax, respectively, and the appearance of an additional elimination phase with a long half-life (~33 hours vs. 18 hours) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 mL/min. The different pharmacokinetic behavior of Spasmo-Urgenin (Trospium Chloride)in patients with severe renal impairment necessitates adjustment of dosage frequency [see Dosage and Administration (2)]. The pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30-80 mL/min.

Hepatic Impairment: In a clinical pharmacokinetic study in patients with mild (Child-Pugh score 5-6) and with moderate (Child-Pugh score 7-8) hepatic impairment, given a single dose of 40 mg immediate-release Spasmo-Urgenin (Trospium Chloride), mean Cmax increased 12% and 63%, respectively, and mean AUC(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. There is no information regarding the effect of severe hepatic impairment on exposure to Spasmo-Urgenin (Trospium Chloride).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Carcinogenicity studies with Spasmo-Urgenin (Trospium Chloride) were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day, approximately 9 times the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 40 mg.

Mutagenesis: Spasmo-Urgenin (Trospium Chloride) was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the rat micronucleus test.

Impairment of Fertility: No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

14 CLINICAL STUDIES

Spasmo-Urgenin (Trospium Chloride) was evaluated for the treatment of patients with overactive bladder who had symptoms of urinary frequency, urgency, and urge incontinence in two U.S. 12-week, placebo-controlled studies and one 9-month open label extension.

Study 1 was a randomized, double-blind, placebo-controlled, parallel-group study in 523 patients. A total of 262 patients received Spasmo-Urgenin (Trospium Chloride) tablets 20 mg twice daily and 261 patients received placebo. The majority of patients were Caucasian (85%) and female (74%) with a mean age of 61 years (range: 21 to 90 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge), urge incontinence episodes of at least 7 per week, and greater than 70 micturitions per week. The patient’s medical history and urinary diary during the treatment-free baseline confirmed the diagnosis. Reductions in urinary frequency, urge incontinence episodes and urinary void volume for placebo and Spasmo-Urgenin (Trospium Chloride) treatment groups are summarized in Table 3 and Figures 2 and 3.

Table 3. Mean (SE) change from baseline to end of treatment (Week 12 or last observation carried forward) for urinary frequency, urge incontinence episodes, and void volume in Study 1


Efficacy endpoint


Placebo

N=256


Spasmo-Urgenin (Trospium Chloride)

N=253


P-value


Urinary frequency/24 hours a,*


Mean baseline


12.9


12.7


Mean change from baseline


-1.3 (0.2)


-2.4 (0.2)


<0.001


Urge incontinence episodes/week b,*


Mean baseline


30.1


27.3


Mean change from baseline


-13.9 (1.2)


-15.4 (1.1)


0.012


Urinary void volume/toilet void (mL)a,c


Mean baseline


156.6


155.1


Mean change from baseline


7.7 (3.1)


32.1 (3.1)


<0.001


a Treatment differences assessed by analysis of variance for ITT:LOCF data set.

b Treatment differences assessed by ranked analysis of variance for ITT:LOCF data set.

c Placebo N=253, Spasmo-Urgenin (Trospium Chloride) N=248.

* Denotes co-primary endpoint

ITT=intent-to-treat, LOCF=last observation carried forward.


Figure 2 – Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 1

Figure 3 – Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 1

Study 2 was nearly identical in design to Study 1. A total of 329 patients received Spasmo-Urgenin (Trospium Chloride) tablets 20 mg twice daily and 329 patients received placebo. The majority of patients were Caucasian (88%) and female (82%) with a mean age of 61 years (range: 19 to 94 years). Entry criteria were identical to Study 1. Reductions in urinary frequency, urge incontinence episodes, and urinary void volume for placebo and Spasmo-Urgenin (Trospium Chloride) treatment groups are summarized in Table 4 and Figures 4 and 5.

Table 4. Mean (SE) change from baseline to end of treatment (Week 12 or last observation carried forward) for urinary frequency, urge incontinence episodes, and void volume in Study 2


Efficacy endpoint


Placebo

N=325


Spasmo-Urgenin (Trospium Chloride)

N=323


P-value


Urinary frequency/24 hours a,*


Mean baseline


13.2


12.9


Mean change from baseline


-1.8 (0.2)


-2.7 (0.2)


<0.001


Urge incontinence episodes/week b


Mean baseline


27.3


26.9


Mean change from baseline


-12.1 (1.0)


-16.1 (1.0)


<0.001


Urinary void volume/toilet void (mL)a,c


Mean baseline


154.6


154.8


Mean change from baseline


9.4 (2.8)


35.6 (2.8)


<0.001


a Treatment differences assessed by analysis of variance for ITT:LOCF data set.

b Treatment differences assessed by ranked analysis of variance for ITT:LOCF data set.

c Placebo N=320, Spasmo-Urgenin (Trospium Chloride) N=319.

* Denotes primary endpoint

ITT=intent-to-treat, LOCF=last observation carried forward.


Figure 4 – Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 2

Figure 5 – Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 2

Figure 2 – Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 1 Figure 3 – Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 1 Figure 4 – Mean Change from Baseline in Urinary Frequency/24 Hours, by Visit: Study 2 Figure 5 – Mean Change from Baseline in Urge Incontinence/Week, by Visit: Study 2

16 HOW SUPPLIED/STORAGE AND HANDLING

Spasmo-Urgenin (Trospium Chloride) tablets USP 20 mg (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on other side) are supplied as follows:

Bottles of 30 NDC 68462-461-30

Bottles of 60 NDC 68462-461-60

Bottles of 500 NDC 68462-461-05

Bottles of 1000 NDC 68462-461-10

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Protect from light.

17 PATIENT COUNSELING INFORMATION

“See FDA-approved Patient Labeling ”

17.1 Angioedema

Patients should be informed that Spasmo-Urgenin (Trospium Chloride), the active ingredient in Spasmo-Urgenin (Trospium Chloride) tablets, may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue Spasmo-Urgenin (Trospium Chloride) tablets and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

17.2 When Not to Use

Prior to treatment, patients should fully understand the risks and benefits of Spasmo-Urgenin. In particular, patients should be informed not to take Spasmo-Urgenin (Trospium Chloride) tablets if they:

  • have urinary retention;
  • gastric retention;
  • uncontrolled narrow-angle glaucoma;
  • are allergic to any component of Spasmo-Urgenin (Trospium Chloride) tablets.

17.3 Administration

Patients should be instructed regarding the recommended dosing and administration of Spasmo-Urgenin (Trospium Chloride) tablets:

  • Take one Spasmo-Urgenin (Trospium Chloride) tablet twice daily with water.
  • Take Spasmo-Urgenin (Trospium Chloride) tablets on an empty stomach or at least 1 hour before a meal.

17.4 Adverse Reactions

Patients should be informed that the most common side effects with Spasmo-Urgenin (Trospium Chloride) are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Because anticholinergics, such as Spasmo-Urgenin (Trospium Chloride), may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

PATIENT INFORMATION

Spasmo-Urgenin (Trospium Chloride) Tablets USP

Read the Patient Information that comes with Spasmo-Urgenin (Trospium Chloride) tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What are Spasmo-Urgenin (Trospium Chloride) tablets?

Spasmo-Urgenin (Trospium Chloride) tablets are a prescription medicine used to treat adults with overactive bladder who have the following symptoms:

  • a strong need to urinate right away;
  • leaking or wetting accidents due to a strong need to urinate right away;
  • a need to urinate often.

Who should not take Spasmo-Urgenin (Trospium Chloride) tablets?

Do not take Spasmo-Urgenin (Trospium Chloride) tablets if you:

  • have trouble emptying your bladder;
  • have delayed or slow emptying of your stomach;
  • have an eye problem called “uncontrolled narrow-angle glaucoma”;
  • are allergic to Spasmo-Urgenin (Trospium Chloride) tablets or any of its ingredients. See the end of this leaflet for a complete list of ingredients.

Spasmo-Urgenin (Trospium Chloride) tablets have not been studied in children under the age of 18 years.

What should I tell my doctor before starting Spasmo-Urgenin (Trospium Chloride) tablets?

Tell your doctor about all of your medical conditions including if you:

  • have any stomach or intestinal problems or problems with constipation;
  • have trouble emptying your bladder or have a weak urine stream;
  • have an eye problem called narrow-angle glaucoma;
  • have kidney problems;
  • have liver problems;
  • are pregnant or planning to become pregnant. It is not known if Spasmo-Urgenin (Trospium Chloride) tablets can harm your unborn baby.
  • are breastfeeding. It is not known if Spasmo-Urgenin (Trospium Chloride) passes into breast milk and if it can harm your baby. You should talk to your doctor about the best way to feed your baby if you are taking Spasmo-Urgenin (Trospium Chloride) tablets.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Spasmo-Urgenin (Trospium Chloride) tablets and certain other medicines can interact and make some side effects worse. Spasmo-Urgenin (Trospium Chloride) tablets can affect how other medicines are handled by the body.

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I take Spasmo-Urgenin (Trospium Chloride) tablets?

Take Spasmo-Urgenin (Trospium Chloride) tablets exactly as prescribed.

  • Take one Spasmo-Urgenin (Trospium Chloride) tablet twice daily with water.
  • Take Spasmo-Urgenin (Trospium Chloride) tablets on an empty stomach or at least 1 hour before a meal.
  • If you take too much Spasmo-Urgenin (Trospium Chloride) call your local Poison Control Center or go to an emergency room right away.

What are the possible side effects of Spasmo-Urgenin (Trospium Chloride) tablets?

Spasmo-Urgenin (Trospium Chloride) tablets may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue. If you experience these symptoms, you should stop taking Spasmo-Urgenin (Trospium Chloride) tablets and get emergency medical help right away.

The most common side effects with Spasmo-Urgenin (Trospium Chloride) tablets are:

  • dry mouth;
  • constipation;
  • headache.

Spasmo-Urgenin (Trospium Chloride) tablets may cause other less common side effects, including:

  • trouble emptying the bladder;
  • blurred vision; and drowsiness. Do not drive or operate heavy machinery until you know how Spasmo-Urgenin (Trospium Chloride) tablets affect you. Alcohol can worsen the drowsiness caused by drugs such as Spasmo-Urgenin (Trospium Chloride) tablets.
  • heat prostration. Due to decreased sweating, heat prostration can occur when drugs such as Spasmo-Urgenin (Trospium Chloride) tablets are used in a hot environment.

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all possible side effects of Spasmo-Urgenin (Trospium Chloride) tablets. For more information, ask your doctor, healthcare professional or pharmacist.

How should I store Spasmo-Urgenin (Trospium Chloride) tablets?

  • Keep Spasmo-Urgenin (Trospium Chloride) tablets and all other medicines out of the reach of children.
  • Store Spasmo-Urgenin (Trospium Chloride) tablets at room temperature, 68° to 77°F (20° to 25°C). Protect from light.
  • Safely dispose of Spasmo-Urgenin (Trospium Chloride) tablets that are out of date or that you no longer need.

General information about Spasmo-Urgenin (Trospium Chloride) tablets

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Spasmo-Urgenin (Trospium Chloride) tabletsfor a condition for which they were not prescribed. Do not give Spasmo-Urgenin (Trospium Chloride) tablets to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Spasmo-Urgenin (Trospium Chloride) tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Spasmo-Urgenin (Trospium Chloride) tablets that is written for health professionals. You can also call Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115.

What are the ingredients in Spasmo-Urgenin (Trospium Chloride) tablets?

Active Ingredient: Spasmo-Urgenin (Trospium Chloride) USP.

Inactive Ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, sucrose, copovidone, titanium dioxide, polyethylene glycol 6000, talc, hypromellose, macrogol, yellow iron oxide, red iron oxide.

Rx only

Manufactured by:

Glenmark Pharmaceuticals Ltd.

India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

December 2014

Glenmark logo

NDC 68462-461-60

Spasmo-Urgenin (Trospium Chloride) TABLETS USP

20 mg

Pharmacist: Dispense the patient information sheet provided separately to each patient.

20mg

Spasmo-Urgenin pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Spasmo-Urgenin available forms, composition, doses:

infoForm 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.


Spasmo-Urgenin destination | category:

infoDestination 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.


Spasmo-Urgenin Anatomical Therapeutic Chemical codes:

infoA 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.


Spasmo-Urgenin pharmaceutical companies:

infoPharmaceutical 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."TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."TROSPIUM CHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Trospium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Spasmo-Urgenin?

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

One visitor reported useful

How is the drug Spasmo-Urgenin useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

One visitor reported frequency of use

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

Few medications can be taken 3 times 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 Spasmo-Urgenin is mentioned below.
Visitors%
3 times in a day1
100.0%

One visitor reported time for results

What is the time duration Spasmo-Urgenin drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sDrugs.com website users needed 5 days to notice the result from using Spasmo-Urgenin drug. The time needed to show improvement in health condition after using the medicine Spasmo-Urgenin need not be same for all the users. It varies based on other factors.
Visitors%
5 days1
100.0%

One visitor reported age

Visitors%
46-601
100.0%

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

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