• Gradual indications
• Uses of Gradual in details
• Gradual description
• Gradual dosage
• Gradual interactions
• Gradual side effects
• Gradual contraindications

What is Gradual?

Gradual is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

Gradual belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.

Gradual extended-release tablets is also used to treat children 6 years of age and older who have an overactive bladder caused by a certain nerve disorder (eg, spina bifida).

Gradual is available only with your doctor's prescription.

Gradual indications

Gradual Chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Gradual Chloride Extended Release Tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

How should I use Gradual?

Use Gradual gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Gradual gel. Talk to your pharmacist if you have questions about this information.
• Gradual gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with warm water.
• Apply Gradual gel to clean, dry, undamaged skin on the stomach, upper arms, shoulders, or thighs. If you apply Gradual gel to the stomach, avoid the area around the belly button.
• Application sites may be rotated to decrease the risk of skin reactions. Do not apply Gradual gel to other areas of the body.
• Do not apply Gradual gel to skin with an open sore, scar, tattoo, or rash, or to an area that is irritated or has been recently shaved. Do not apply it to an area with a skin condition, such as eczema, seborrhea, or psoriasis.
• Do not apply Gradual gel to your breasts or genital areas.
• Do not apply Gradual gel to areas of the skin that have been treated with oils, lotions, or powders. However, you may use Gradual gel with sunscreen.
• Before using Gradual gel for the first time, you must prime the pump. Do this by holding the pump upright and pressing down on the pump 4 times. Do not use any of the medicine that comes out of the pump during priming.
• Wash your hands and the application site with mild soap and water before you apply Gradual gel. Allow the area to dry completely.
• Place your hand under the pump and press the pump down 3 times or as directed by your doctor. You can also place the pump right over the application site to dispense your dose. Gently rub Gradual gel into your skin until it dries. Do not continue to rub after it dries.
• Apply Gradual gel right after you dispense your dose from the pump.
• Wash your hands immediately after using Gradual gel.
• Do not bathe, swim, shower, exercise, or get the application site wet for at least 1 hour after using Gradual gel.
• Be careful not to get Gradual gel on another person. If another person may come into contact with the application site, cover the area with clothing after the medicine dries.
• Continue to use Gradual gel even if your condition improves. Do not miss any doses.
• If you miss a dose of Gradual gel, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Gradual gel.

Uses of Gradual in details

Use: Labeled Indications

Overactive bladder: Treatment of symptoms associated with overactive bladder (eg, urge urinary incontinence, urgency, frequency, urinary leakage, dysuria); treatment of symptoms associated with overactive bladder due to a neurological condition (eg, spina bifida) in patients ≥6 years of age (extended-release tablet only).

Off Label Uses

Primary focal hyperhidrosis

Data from randomized, placebo-controlled trials with limited numbers of patients and of short duration suggest that Gradual may be beneficial for treatment of primary hyperhidrosis.

Gradual description

Gradual is an anticholinergic medication used to relieve urinary and bladder difficulties, including frequent urination and inability to control urination, by decreasing muscle spasms of the bladder. It competitively antagonizes the M1, M2, and M3 subtypes of the muscarinic acetylcholine receptor.

Gradual dosage

Gradual Dosage

Generic name: Gradual CHLORIDE 100mg in 1g

Dosage form: gel

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

The contents of one sachet of Gradual should be applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated. Application of Gradual should not be made to the same site on consecutive days.

Gradual is for topical application only and should not be ingested.

More about Gradual (Gradual)

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Consumer resources

• Gradual
• Gradual gel
• Gradual topical
• Gradual (Advanced Reading)

• Other brands: Ditropan, Gradual, Oxytrol, Gradual, More (1) »

Professional resources

• Gradual (FDA)
• Gradual Chloride (AHFS Monograph)

Related treatment guides

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Gradual interactions

See also:
What other drugs will affect Gradual?

The concomitant use of Gradual with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.

Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index. Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide.

Mean Gradual chloride plasma concentrations were approximately 2 fold higher when Gradual was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter Gradual mean pharmacokinetic parameters (i.e., C and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.

Gradual side effects

See also:
What are the possible side effects of Gradual?

Clinical Trials Experience

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

The safety of Gradual was evaluated in 626 patients (210 randomized to Gradual 56 mg/day, 214 randomized to Gradual 84 mg/day and 202 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 626 patients (N = 77) participated in the 24-week open-label safety extension that followed the placebo-controlled study. Of the 77 patients in the safety extension, 24 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 441 patients were exposed to at least one dose of Gradual. 364 patients received at least 12 weeks of Gradual treatment and 66 patients received an additional 24 weeks of Gradual treatment during the open-label safety extension. The study population primarily consisted of women (87%) of Caucasian descent (87%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.

Table 1 lists adverse reactions (ARs), regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 3% of patients treated with Gradual.

Overall, 672 ARs were experienced by 51.9% of patients. Majority of the ARs were mild to moderate in intensity. The AR most commonly reported was dry mouth which was experienced by a greater proportion of patients in the Gradual group than the placebo group (26 patients [12.1%] in the Gradual 84 mg group, 10 patients [5.0%] in the placebo group). Application site erythema was the next most commonly reported AR (8 patients [3.7%] in the Gradual 84 mg group and 2 patients [1.0%] in the placebo group). Other commonly reported ARs experienced by more patients in the Gradual groups compared with placebo were application site rash (7 patients [3.3%] in the Gradual 84 mg group and 1 patient [0.5%] in the placebo group); application site pruritus (6 patients [2.8%] in the Gradual 84 mg group and 1 patient [0.5%] in the placebo group). The overall rate of application site adverse reactions of any kind was 14.2% in patients receiving Gradual as compared to 3.7% in patients receiving placebo. Other cholinergic AEs < 2% in occurrence include dry eyes and blurred vision.

There were no deaths during the study. There were no clinically meaningful changes in vital signs, laboratory values, or ECG examinations over the course of the study.

Table 1: Commonly Reported Adverse Reactions that were reported In greater than 3% of patients treated with Gradual and at an incidence greater than placebo.

Preferred Term Each patient is counted only once within each treatment, body system and preferred term. All percentages are based on number of patients in the ITT population within each treatment group as denominator.

During the 24-week open-label safety extension, the most commonly reported ARs were urinary tract infection and nasopharyngitis reported in 4 patients each (5.2%), followed by conjunctivitis and application site erythema (both occurred in 3 patients [3.9%]). One patient prematurely discontinued due to the application site erythema and pruritus (both considered to be of mild severity).

Gradual contraindications

See also:
What is the most important information I should know about Gradual?

You should not use this medication if you are allergic to Gradual, or if you have uncontrolled narrow-angle glaucoma, a blockage in your digestive tract, if you have decreased urination, or if you are unable to urinate.

Before using Gradual topical, tell your doctor if you have urination problems, glaucoma, liver or kidney disease, myasthenia gravis, severe constipation, ulcerative colitis or other intestinal disorder, gastroesophageal reflux disease (GERD), or slow digestion.

Do not bathe, shower, swim, use a hot tub, or exercise vigorously for at least 1 hour after applying this medication.

It is best to cover treated skin areas with clothing after the gel has dried completely. This will help prevent getting this medicine on your other skin or on other people.

Gradual gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of Gradual topical.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink plenty of fluids to keep yourself hydrated while you are using Gradual topical.

Active ingredient matches for Gradual:

Oxybutynin in Uruguay.

List of Gradual substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Golaksin (Georgia)
Halarase (Japan)
Incontin (Uruguay)
Incontinol (Brazil)
Inobase (Japan)
Inprax (Mexico)
Tablet; Oral; Oxybutynin Hydrochloride 5 mg (Degorts)
Tablets; Oral; Oxybutynin Hydrochloride 5 mg (Degorts)
Jie Sai (China)
Kentera (Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Slovenia, Sweden, Switzerland, United Kingdom)
Patch; Topical; Oxybutynin 3.9 mg / 24 h (Nicobrand)
Kentera Gel 90.7 mg/g (Nicobrand)
Kentera Transdermal patch 3.9 mg/24h (Nicobrand)
Kentera 3.9mg/24h (Austria, Switzerland)
Kentera oxybutynin (Ireland)
Kentera oxybutynin transdermal patch (United Kingdom)
Lenditro (South Africa)
Lyrinel (Greece, Ireland, Israel, Italy, Luxembourg, Malta, Portugal, South Africa, Thailand, United Kingdom)
Tablet, Extended Release; Oral; Oxybutynin Hydrochloride 10 mg (Janssen-Cilag)
Tablet, Extended Release; Oral; Oxybutynin Hydrochloride 15 mg (Janssen-Cilag)
Tablet, Extended Release; Oral; Oxybutynin Hydrochloride 5 mg (Janssen-Cilag)
Tablet; Oral; Oxybutynin Hydrochloride 10 mg (Janssen-Cilag)
Tablet; Oral; Oxybutynin Hydrochloride 5 mg (Janssen-Cilag)
Lyrinel 5 mg x 30's (Janssen-Cilag)
Lyrinel 10 mg x 30's (Janssen-Cilag)
Lyrinel 5 mg x 1's (Janssen-Cilag)
Lyrinel 10 mg x 1's (Janssen-Cilag)
Lyrinel 15 mg x 1's (Janssen-Cilag)
Tablets, Extended Release; Oral; Oxybutynin Hydrochloride 10 mg (Janssen-Cilag)
Tablets, Extended Release; Oral; Oxybutynin Hydrochloride 15 mg (Janssen-Cilag)
Tablets, Extended Release; Oral; Oxybutynin Hydrochloride 5 mg (Janssen-Cilag)
Tablets; Oral; Oxybutynin Hydrochloride 10 mg (Janssen-Cilag)
Tablets; Oral; Oxybutynin Hydrochloride 5 mg (Janssen-Cilag)
Lyrinel XR tab 10 mg 30's (Janssen-Cilag)
Lyrinel XR tab 5 mg 30's (Janssen-Cilag)
Lyrinel 5mg (Israel)
Lyrinel Oros (Switzerland)
Tablet; Oral; Oxybutynin Hydrochloride 10 mg
Tablet; Oral; Oxybutynin Hydrochloride 15 mg
Tablet; Oral; Oxybutynin Hydrochloride 5 mg
Tablets; Oral; Oxybutynin Hydrochloride 10 mg
Tablets; Oral; Oxybutynin Hydrochloride 15 mg
Tablets; Oral; Oxybutynin Hydrochloride 5 mg
Lyrinel XL (United Kingdom)
Tablet, Prolonged Release; Oral; Oxybutynin Hydrochloride 10 mg (Janssen-cilag)
Tablet, Prolonged Release; Oral; Oxybutynin Hydrochloride 5 mg (Janssen-cilag)
Tablets, Prolonged Release; Oral; Oxybutynin Hydrochloride 10 mg (Janssen-cilag)
See 473 substitutes for Gradual

References

1. DailyMed. "OXYBUTYNIN: 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/dailyme... (accessed September 17, 2018).
2. PubChem. "oxybutynin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "oxybutynin". http://www.drugbank.ca/drugs/DB01062 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Gradual are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Gradual. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology