Solider5 mg

Solider is an antimuscarinic (anticholinergic) agent indicated for the treatment of the following condition:

Established / FDA-approved use

• Overactive bladder (OAB): Solider is indicated for the treatment of overactive bladder in adults with symptoms of urinary urgency, urinary frequency, and urge urinary incontinence.

Guideline-supported / combination-therapy use

• Pediatric neurogenic detrusor overactivity (NDO): An oral suspension formulation of Solider is used, in combination with clean intermittent catheterization (CIC), for the treatment of neurogenic detrusor overactivity in children (approved age ranges vary by formulation/label). This is an add-on/combination indication, not a standalone use.

Solider is not indicated for stress incontinence or for the treatment of urinary tract infection.

Each tablet contains Solifenacin Succinate equivalent to solifenacin base (commonly available as 5 mg and 10 mg strengths). Excipients vary by manufacturer and formulation (film-coated tablet or oral suspension).

Solider is a synthetic muscarinic receptor antagonist belonging to the antimuscarinic class of drugs used in the management of overactive bladder. It works by blocking muscarinic (M3) receptors on the detrusor smooth muscle of the bladder, reducing involuntary bladder contractions and easing symptoms of urgency, frequency, and urge incontinence.

Solider is available as oral film-coated tablets (typically 5 mg and 10 mg) and, in some markets, as an oral suspension for pediatric use.

Solider belongs to the antimuscarinic (anticholinergic) class of drugs, specifically the urinary antispasmodics used for overactive bladder.

Solifenacin Succinate is a competitive muscarinic receptor antagonist with relative selectivity for the M3 receptor subtype found on bladder detrusor smooth muscle and salivary gland tissue. By blocking acetylcholine-mediated stimulation of M3 receptors, Solifenacin Succinate reduces involuntary detrusor muscle contractions, increases bladder capacity, and decreases the frequency of urgency and urge incontinence episodes.

Pharmacokinetics: Solifenacin Succinate is absorbed slowly after oral administration (peak plasma concentration in approximately 3–8 hours), undergoes extensive hepatic metabolism primarily via the CYP3A4 enzyme system, and has a long elimination half-life of approximately 45–68 hours, supporting once-daily dosing. It is eliminated mainly via the kidneys and, to a lesser extent, the feces.

Solider tablets are taken orally, once daily, swallowed whole with water, with or without food, preferably at the same time each day for consistent symptom control.

The following are clinically significant, well-documented interactions with Solider:

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): these increase plasma concentrations of Solider; the dose of Solider should be limited to 5 mg once daily when co-administered.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): these may reduce plasma concentrations of Solider, potentially reducing its efficacy.
• Other antimuscarinic/anticholinergic drugs: concomitant use with other anticholinergic medications (e.g., certain antihistamines, tricyclic antidepressants, other bladder antimuscarinics) may produce additive anticholinergic effects such as dry mouth, constipation, blurred vision, and cognitive impairment, particularly in elderly patients.
• Other QT-interval-prolonging drugs: because Solider can prolong the QT interval in a dose-related manner, caution is warranted when combined with other drugs known to prolong QT interval or in patients with risk factors for arrhythmia.

Side effects of Solider are largely related to its antimuscarinic mechanism.

Very common / common

• Dry mouth (the most characteristic and frequently reported effect)
• Constipation
• Blurred vision
• Dizziness and headache
• Dyspepsia (indigestion)
• Urinary tract infection

Less common but clinically important

• Dry eyes
• Nausea, abdominal discomfort

Serious (uncommon but important)

• Urinary retention
• Severe constipation, fecal impaction, or intestinal obstruction/ileus
• Angioedema and hypersensitivity reactions (including anaphylaxis)
• QT interval prolongation and, rarely, torsades de pointes, particularly at higher doses or in at-risk patients
• Confusion, hallucinations, or other cognitive/CNS effects, notably in elderly patients

Pregnancy: There are limited human data on the use of Solider during pregnancy. Solider should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus. A physician should always be consulted before use in pregnancy.

Lactation: It is not well established whether Solider is excreted in human breast milk. Because many drugs are excreted in breast milk and antimuscarinic effects could theoretically affect a nursing infant, a decision should be made whether to discontinue breastfeeding or discontinue Solider, taking into account the importance of the drug to the mother, in consultation with a physician.

The following precautions apply to the use of Solider:

• Elderly patients: increased susceptibility to anticholinergic effects, including confusion, cognitive impairment, and increased fall risk due to overall anticholinergic burden; use with caution and monitor closely.
• Reduced gastrointestinal motility: use with caution in patients with conditions such as severe constipation or obstructive gastrointestinal disorders, due to risk of worsening these conditions (see Contraindications for gastric retention).
• Myasthenia gravis: use with caution, as antimuscarinic agents may worsen symptoms of this condition.
• Controlled narrow-angle glaucoma: use only if potential benefit outweighs risk, and monitor intraocular effects (uncontrolled narrow-angle glaucoma is a contraindication — see Contraindications).
• QT prolongation risk: caution in patients with risk factors for QT prolongation or with concomitant QT-prolonging drugs (see Interactions).
• Heat prostration: antimuscarinic-induced decreased sweating may cause heat prostration in high ambient temperatures.
• Patients should take Solider exactly as prescribed and consult their physician before combining it with other medicines, including over-the-counter products.

Overdose with Solider may cause severe anticholinergic effects, including dry mouth, blurred vision, tachycardia, urinary retention, mydriasis (dilated pupils), agitation, and, in severe cases, central nervous system effects such as confusion or hallucinations.

There is no specific antidote. In case of suspected overdose, seek immediate medical attention or contact a poison control center/emergency services right away. Management is supportive and symptomatic and should be carried out under medical supervision; do not attempt home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: Solider should be used with caution in elderly patients due to increased susceptibility to anticholinergic adverse effects (confusion, cognitive impairment, falls); no specific dose adjustment based on age alone is generally required, but overall anticholinergic burden should be considered.

Renal impairment: dose adjustment required in severe renal impairment (see Dosage and Administration); avoid combination of severe renal impairment with strong CYP3A4 inhibitors (see Contraindications).

Hepatic impairment: dose adjustment required in moderate hepatic impairment; use is contraindicated in severe hepatic impairment (see Contraindications).

Pediatric use: see Pediatric Uses below.

Duration of treatment with Solider for overactive bladder is individualized based on symptom response, typically assessed after 4–8 weeks of therapy, with continued use guided by ongoing physician review of benefit and tolerability.

Antimuscarinic agent (anticholinergic), urinary antispasmodic.

Solifenacin Succinate acts as a competitive antagonist at muscarinic acetylcholine receptors, with relative functional selectivity for the M3 receptor subtype on urinary bladder detrusor smooth muscle. By inhibiting acetylcholine-mediated contraction of the detrusor muscle, it reduces involuntary bladder contractions, increases bladder capacity, and decreases urinary urgency, frequency, and urge incontinence episodes.

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The tablet formulation of Solider has not established safety and efficacy for the treatment of overactive bladder in pediatric patients and is not recommended for this use in children.

An oral suspension formulation of Solider is approved in some markets for the treatment of neurogenic detrusor overactivity in pediatric patients (in defined age ranges), used in combination with clean intermittent catheterization (CIC) and under specialist supervision, with weight-based dosing. Safety and efficacy outside these established pediatric indications and age ranges have not been established.