Klavox may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Klavox in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Klavox in the following countries:
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Trypsine may be available in the countries listed below.
Trypsine (DCF) is known as Trypsin in the US.
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Glossary
| DCF | Dénomination Commune Française |
Kofen may be available in the countries listed below.
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Kofen in the following countries:
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Ketodar may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Ketodar in the following countries:
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Lumin may be available in the countries listed below.
Mianserin hydrochloride (a derivative of Mianserin) is reported as an ingredient of Lumin in the following countries:
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Mécasermine may be available in the countries listed below.
Mécasermine (DCF) is known as Mecasermin in the US.
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Glossary
| DCF | Dénomination Commune Française |
Supero may be available in the countries listed below.
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Supero in the following countries:
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Clodronique (acide) may be available in the countries listed below.
Clodronique (acide) (DCF) is also known as Clodronic Acid (Rec.INN)
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Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Keto-A may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Keto-A in the following countries:
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Ranitidina Generis may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidina Generis in the following countries:
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Ivogell may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ivermectin is reported as an ingredient of Ivogell in the following countries:
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Inmecin may be available in the countries listed below.
Indometacin is reported as an ingredient of Inmecin in the following countries:
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Opsamox may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Opsamox in the following countries:
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Postmarketing reports indicate that the effects of Botox and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses. [See Warnings and Precautions (5.2)]
Botox (onabotulinumtoxinA) for injection is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Botox is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).
Important limitations
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
Botox is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).
Important limitations
Safety and effectiveness of Botox have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity. Safety and effectiveness of Botox have not been established for the treatment of spasticity in pediatric patients under age 18 years. Botox has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with Botox is not intended to substitute for usual standard of care rehabilitation regimens.
Botox is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
Botox is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
Important limitations
The safety and effectiveness of Botox for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive Botox for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of Botox have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
Botox is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
The potency Units of Botox (onabotulinumtoxinA) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Botox cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see Warnings and Precautions (5.1) and Description (11)].
Indication specific dosage and administration recommendations should be followed. In treating adult patients for one or more indications, the maximum cumulative dose should generally not exceed 360 Units, in a 3 month interval.
The safe and effective use of Botox depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering Botox must understand the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures. An understanding of standard electromyographic techniques is also required for treatment of strabismus and of upper limb spasticity, and may be useful for the treatment of cervical dystonia.
Use caution when Botox treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Botox is supplied in single-use 100 Units and 200 Units per vial. Prior to injection, reconstitute each vacuum-dried vial of Botox with sterile, non-preserved 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detrusor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix Botox with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. Botox should be administered within 24 hours after reconstitution. During this time period, reconstituted Botox should be stored in a refrigerator (2° to 8°C).
| Diluent* Added to 100 Unit Vial | Resulting Dose Units per 0.1 mL | Diluent* Added to 200 Unit Vial | Resulting Dose Units per 0.1 mL |
|---|---|---|---|
*Preservative-free 0.9% Sodium Chloride Injection, USP Only | |||
| 1 mL 2 mL 4 mL 8 mL | 10 Units 5 Units 2.5 Units 1.25 Units | 1 mL 2 mL 4 mL 8 mL 10 mL | 20 Units 10 Units 5 Units 2.5 Units 2 Units |
Note: These dilutions are calculated for an injection volume of 0.1 mL. A decrease or increase in the Botox dose is also possible by administering a smaller or larger injection volume - from 0.05 mL (50% decrease in dose) to 0.15 mL (50% increase in dose).
An injection of Botox is prepared by drawing into an appropriately sized sterile syringe an amount of the properly reconstituted toxin slightly greater than the intended dose. Air bubbles in the syringe barrel are expelled and the syringe is attached to an appropriate injection needle. Patency of the needle should be confirmed. A new, sterile, needle and syringe should be used to enter the vial on each occasion for removal of Botox.
Reconstituted Botox should be clear, colorless, and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and whenever the solution and the container permit.
Patients should not have an acute urinary tract infection prior to treatment. Prophylactic antibiotics (except aminoglycosides, see Drug Interactions (7)) should be administered 1-3 days pre-treatment, on the treatment day, and 1-3 days post-treatment.
Patients should discontinue anti-platelet therapy at least 3 days before the injection procedure. Patients on anti-coagulant therapy need to be managed appropriately to decrease the risk of bleeding.
Appropriate caution should be exercised when performing a cystoscopy.
An intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia may be used prior to injection, per local site practice. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
The recommended dose is 200 Units of Botox per treatment, and should not be exceeded.
Reconstitute a 200 Unit vial of Botox with 6 mL of 0.9% non-preserved saline solution and mix the vial gently. Draw 2 mL from the vial into each of three 10 mL syringes. Complete the reconstitution by adding 8 mL of 0.9% non-preserved saline solution into each of the 10 mL syringes, and mix gently. This will result in three 10 mL syringes each containing 10 mL (~67 Units in each), for a total of 200 Units of reconstituted Botox. Use immediately after reconstitution in the syringe. Dispose of any unused saline.
Alternatively, reconstitute two 100 Unit vials of Botox, each with 6 mL of 0.9% non-preserved saline solution and mix the vials gently. Draw 4 mL from each vial into each of two 10 mL syringes. Draw the remaining 2 mL from each vial into a third 10 mL syringe. Complete the reconstitution by adding 6 mL of 0.9% non-preserved saline solution into each of the 10 mL syringes, and mix gently. This will result in three 10 mL syringes each containing 10 mL (~67 Units in each), for a total of 200 Units of reconstituted Botox. Use immediately after reconstitution in the syringe. Dispose of any unused saline.
Reconstituted Botox (200 Units/30 mL) is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but over-distension should be avoided.
The injection needle should be filled (primed) with approximately 1 mL of reconstituted Botox prior to the start of injections (depending on the needle length) to remove any air.
The needle should be inserted approximately 2 mm into the detrusor, and 30 injections of 1 mL (~6.7 Units) each (total volume of 30 mL) should be spaced approximately 1 cm apart (see Figure 1). For the final injection, approximately 1 mL of sterile normal saline should be injected so the full dose is delivered. After the injections are given, the saline used for bladder wall visualization should be drained. The patient should be observed for at least 30 minutes post-injection.
Patients should be considered for re-injection when the clinical effect of the previous injection diminishes (median time to qualification for re-treatment in the double-blind, placebo-controlled clinical studies was 295-337 days [42-48 weeks] for Botox 200 Units), but no sooner than 12 weeks from the prior bladder injection.
Figure 1: Injection Pattern for Detrusor Overactivity associated with a Neurologic Condition
The recommended dilution is 200 Units/4 mL or 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL (see Table 1). The recommended dose for treating chronic migraine is 155 Units administered intramuscularly (IM) using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas as specified in the diagrams and Table 2 below. A one inch needle may be needed in the neck region for patients with thick neck muscles. With the exception of the procerus muscle, which should be injected at one site (midline), all muscles should be injected bilaterally with half the number of injection sites administered to the left, and half to the right side of the head and neck. The recommended re-treatment schedule is every 12 weeks.
Diagrams 1-4: Recommended Injection Sites (A thru G) for Chronic Migraine
| Head/Neck Area | Recommended Dose (Number of Sitesa) |
|---|---|
a Each IM injection site = 0.1 mL = 5 Units Botox | |
b Dose distributed bilaterally | |
| Frontalisb | 20 Units divided in 4 sites |
| Corrugatorb | 10 Units divided in 2 sites |
| Procerus | 5 Units in 1 site |
| Occipitalisb | 30 Units divided in 6 sites |
| Temporalisb | 40 Units divided in 8 sites |
| Trapeziusb | 30 Units divided in 6 sites |
| Cervical Paraspinal Muscle Groupb | 20 Units divided in 4 sites |
| Total Dose: | 155 Units divided in 31 sites |
Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient's response to previous treatment, or adverse event history with Botox. In clinical trials, doses ranging from 75 Units to 360 Units were divided among selected muscles at a given treatment session.
| Muscle | Recommended Dose Total Dosage (Number of Sites) |
|---|---|
| Biceps Brachii | 100 Units-200 Units divided in 4 sites |
| Flexor Carpi Radialis | 12.5 Units-50 Units in 1 site |
| Flexor Carpi Ulnaris | 12.5 Units-50 Units in 1 site |
| Flexor Digitorum Profundus | 30 Units-50 Units in 1 site |
| Flexor Digitorum Sublimis | 30 Units-50 Units in 1 site |
The recommended dilution is 200 Units/4 mL or 100 Units/2 mL with 0.9% non-preserved sterile saline (see Table 1). The lowest recommended starting dose should be used, and no more than 50 Units per site should generally be administered. An appropriately sized needle (e.g., 25-30 gauge) may be used for superficial muscles, and a longer 22 gauge needle may be used for deeper musculature. Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques is recommended.
Repeat Botox treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks after the previous injection. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Botox and muscles to be injected.
A double-blind, placebo-controlled study enrolled patients who had extended histories of receiving and tolerating Botox injections, with prior individualized adjustment of dose. The mean Botox dose administered to patients in this study was 236 Units (25th to 75th percentile range of 198 Units to 300 Units). The Botox dose was divided among the affected muscles [see Clinical Studies (14.4)].
Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The initial dose for a patient without prior use of Botox should be at a lower dose, with subsequent dosing adjusted based on individual response. Limiting the total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia [see Warnings and Precautions (5.2, 5.5, 5.6)].
The recommended dilution is 200 Units/2 mL, 200 Units/4 mL, 100 Units/1 mL, or 100 Units/2 mL with 0.9% non-preserved sterile saline, depending on volume and number of injection sites desired to achieve treatment objectives (see Table 1). In general, no more than 50 Units per site should be administered. An appropriately sized needle (e.g., 25-30 gauge) may be used for superficial muscles, and a longer 22 gauge needle may be used for deeper musculature. Localization of the involved muscles with electromyographic guidance may be useful.
Clinical improvement generally begins within the first two weeks after injection with maximum clinical benefit at approximately six weeks post-injection. In the double-blind, placebo-controlled study most subjects were observed to have returned to pre-treatment status by 3 months post-treatment.
The recommended dose is 50 Units per axilla. The hyperhidrotic area to be injected should be defined using standard staining techniques, e.g., Minor's Iodine-Starch Test. The recommended dilution is 100 Units/4 mL with 0.9% preservative-free sterile saline (see Dilution Table). Using a 30 gauge needle, 50 Units of Botox (2 mL) is injected intradermally in 0.1 to 0.2 mL aliquots to each axilla evenly distributed in multiple sites (10-15) approximately 1-2 cm apart.
Repeat injections for hyperhidrosis should be administered when the clinical effect of a previous injection diminishes.
Instructions for the Minor's Iodine-Starch Test Procedure:
Patients should shave underarms and abstain from use of over-the-counter deodorants or antiperspirants for 24 hours prior to the test. Patient should be resting comfortably without exercise, hot drinks for approximately 30 minutes prior to the test. Dry the underarm area and then immediately paint it with iodine solution. Allow the area to dry, then lightly sprinkle the area with starch powder. Gently blow off any excess starch powder. The hyperhidrotic area will develop a deep blue-black color over approximately 10 minutes.
Each injection site has a ring of effect of up to approximately 2 cm in diameter. To minimize the area of no effect, the injection sites should be evenly spaced as shown in Figure 2.
Figure 2: Injection Pattern for Primary Axillary Hyperhidrosis
Each dose is injected to a depth of approximately 2 mm and at a 45° angle to the skin surface, with the bevel side up to minimize leakage and to ensure the injections remain intradermal. If injection sites are marked in ink, do not inject Botox directly through the ink mark to avoid a permanent tattoo effect.
For blepharospasm, reconstituted Botox is injected using a sterile, 27-30 gauge needle without electromyographic guidance. The initial recommended dose is 1.25 Units-2.5 Units (0.05 mL to 0.1 mL volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. Avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections, and thereby reducing diffusion into the inferior oblique, may reduce the complication of diplopia. Ecchymosis occurs easily in the soft eyelid tissues. This can be prevented by applying pressure at the injection site immediately after the injection.
The recommended dilution to achieve 1.25 Units is 100 Units/8 mL; for 2.5 Units it is 100 Units/4 mL (see Table 1).
In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient, usually defined as an effect that does not last longer than two months. However, there appears to be little benefit obtainable from injecting more than 5 Units per site. Some tolerance may be found when Botox is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent.
The cumulative dose of Botox treatment for blepharospasm in a 30-day period should not exceed 200 Units.
Botox is intended for injection into extraocular muscles utilizing the electrical activity recorded from the tip of the injection needle as a guide to placement within the target muscle. Injection without surgical exposure or electromyographic guidance should not be attempted. Physicians should be familiar with electromyographic technique.
To prepare the eye for Botox injection, it is recommended that several drops of a local anesthetic and an ocular decongestant be given several minutes prior to injection.
The volume of Botox injected for treatment of strabismus should be between 0.05-0.15 mL per muscle.
The initial listed doses of the reconstituted Botox [see Dosage and Administration (2.2)] typically create paralysis of the injected muscles beginning one to two days after injection and increasing in intensity during the first week. The paralysis lasts for 2-6 weeks and gradually resolves over a similar time period. Overcorrections lasting over six months have been rare. About one half of patients will require subsequent doses because of inadequate paralytic response of the muscle to the initial dose, or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment.
Initial doses in Units
Use the lower listed doses for treatment of small deviations. Use the larger doses only for large deviations.
Subsequent doses for residual or recurrent strabismus
The recommended dilution to achieve 1.25 Units is 100 Units/8 mL; for 2.5 Units it is 100 Units/4 mL (see Table 1).
Single-use, sterile 100 Units or 200 Units vacuum-dried powder for reconstitution only with sterile, non-preserved 0.9% Sodium Chloride Injection USP prior to injection.
Botox is contraindicated in patients who are hypersensitive to any botulinum toxin preparation or to any of the components in the formulation [see Warnings and Precautions (5.4)].
Botox is contraindicated in the presence of infection at the proposed injection site(s).
Intradetrusor injection of Botox is contraindicated in patients with detrusor overactivity associated with a neurologic condition who have acute urinary tract infection, and in patients with acute urinary retention who are not routinely performing clean intermittent self-catheterization (CIC).
The potency Units of Botox are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Botox cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see Dosage and Administration (2.1), Description (11)].
Postmarketing safety data from Botox and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders occur.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Botox/Botox Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported.
No definitive serious adverse event reports of distant spread of toxin effect associated with Botox for blepharospasm at the recommended dose (30 Units and below), strabismus, or for chronic migraine at the labeled doses have been reported.
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received Botox injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Some patients had pre-existing dysphagia or significant debility. (Safety and effectiveness have not been established for indications pertaining to these injection sites.) Pneumothorax associated with injection procedure has been reported following the administration of Botox near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of Botox should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined.
Treatment with Botox and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved [see Warnings and Precautions (5.2)].
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients.
Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscle have been reported to be at greater risk for dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Injections into the levator scapulae may be associated with an increased risk of upper respiratory infection and dysphagia.
Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from therapeutic doses of Botox [see Adverse Reactions (6.1)].
Patients with compromised respiratory status treated with Botox for upper limb spasticity should be monitored closely. In a double-blind, placebo-controlled, parallel group study in patients with stable reduced pulmonary function (defined as FEV1 40-80% of predicted value and FEV1/FVC ≤ 0.75), the event rate in change of Forced Vital Capacity ≥15% or ≥20% was generally greater in patients treated with Botox than in patients treated with placebo (see Table 4).
Differences from placebo were not statistically significant | ||||||
| Botox 360 Units | Botox 240 Units | Placebo | ||||
| ≥15% | ≥20% | ≥15% | ≥20% | ≥15% | ≥20% | |
| Week 1 | 4% | 0% | 3% | 0% | 7% | 3% |
| Week 6 | 7% | 4% | 4% | 2% | 2% | 2% |
| Week 12 | 10% | 5% | 2% | 1% | 4% | 1% |
In patients with reduced lung function, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with Botox than in patients treated with placebo [see Warnings and Precautions (5.10)].
In an ongoing double-blind, placebo-controlled, parallel group study in adult patients with detrusor overactivity associated with a neurologic condition and restrictive lung disease of neuromuscular etiology [defined as FVC 50-80% of predicted value in patients with spinal cord injury between C5 and C8, or MS] the event rate in change of Forced Vital Capacity ≥15% or ≥20% was generally greater in patients treated with Botox than in patients treated with placebo (see Table 5).
| Botox 200 Units | Placebo | |||
| ≥15% | ≥20% | ≥15% | ≥20% | |
| Week 2 | 0/12 (0%) | 0/12 (0%) | 1/11 (9%) | 0/11 (0%) |
| Week 6 | 2/11 (18%) | 1/11 (9%) | 0/11 (0%) | 0/11 (0%) |
| Week 12 | 0/11 (0%) | 0/11 (0%) | 0/6 (0%) | 0/6 (0%) |
Reduced blinking from Botox injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other means.
During the administration of Botox for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred. It is recommended that appropriate instruments to decompress the orbit be accessible.
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spasticity with Botox (3% at 251 Units-360 Units total dose), compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with Botox (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%).
Autonomic dysreflexia associated with intradetrusor injections of Botox could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with Botox 200 Units compared with placebo (1.5% versus 0.4%, respectively).
In double-blind, placebo-controlled trials, the proportion of subjects who were not using clean intermittent catheterization (CIC) prior to injection and who subsequently required catheterization for urinary retention following treatment with Botox or placebo is shown in Table 6. The duration of post-injection catheterization is also shown.
| Timepoint | Botox 200 Unit (N=108) | Placebo (N=104) |
|---|---|---|
| Proportion of Patients Catheterizing for Urinary Retention | ||
| At any time during complete treatment cycle | 33 (30.6%) | 7 (6.7%) |
| Duration of Catheterization for Urinary Retention (Days) | ||
| Median | 289 | 358 |
| Min, Max | 1, 530 | 2, 379 |
Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI (see Table 7).
| Timepoint | MS | SCI | ||
|---|---|---|---|---|
| Botox 200 Unit (N=86) | Placebo (N=88) | Botox 200 Unit (N=22) | Placebo (N=16) | |
| At any time during complete treatment cycle | 27 (31%) | 4 (5%) | 6 (27%) | 3 (19%) |
Due to the risk of urinary retention, only patients who are willing and/or able to initiate catheterization post-treatment, if required, should be considered for treatment.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks. Catheterization should be instituted if PVR urine volume exceeds 200 mL and continued until PVR falls below 200 mL. Patients should be instructed to contact their physician if they experience difficulty in voiding as catheterization may be required.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.
The following adverse reactions to Botox (onabotulinumtoxi
Kalpiren may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Kalpiren in the following countries:
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Treatment of the symptoms of irritable bowel syndrome. It may also be used for other conditions as determined by your doctor.
Bentyl Syrup is an anticholinergic. It works by blocking a chemical in the smooth muscle of the stomach and intestines causing them to relax, which reduces cramping.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Bentyl Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Bentyl Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Bentyl Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Bentyl Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Bentyl Syrup.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Blurred vision; constipation; decreased sweating; difficulty sleeping; dizziness; drowsiness; dry mouth; headache; lightheadedness; loss of taste; nausea; nervousness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing your eyes; difficulty moving; difficulty speaking; difficulty urinating; disorientation; exaggerated sense of well-being; fainting; hallucinations; pounding in the chest; rapid heartbeat; short-term memory loss; unusual weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
See also: Bentyl side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include convulsions (seizures); difficulty breathing; dilated pupils; disorientation; excessive thirst; flushed, hot, dry skin; hallucinations or unusual behavior; muscle weakness; nausea; rapid heartbeat and breathing; restlessness; severe dizziness or drowsiness; severe dry mouth; vomiting.
Store at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bentyl Syrup out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Bentyl Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Codeine HCl PCH may be available in the countries listed below.
Codeine hydrochloride (a derivative of Codeine) is reported as an ingredient of Codeine HCl PCH in the following countries:
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Pronison may be available in the countries listed below.
Prednisone is reported as an ingredient of Pronison in the following countries:
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Symepezil may be available in the countries listed below.
Donepezil hydrochloride (a derivative of Donepezil) is reported as an ingredient of Symepezil in the following countries:
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Tamsulosin-CT may be available in the countries listed below.
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosin-CT in the following countries:
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Medicaine may be available in the countries listed below.
Mepivacaine is reported as an ingredient of Medicaine in the following countries:
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Naproson may be available in the countries listed below.
Naproxen is reported as an ingredient of Naproson in the following countries:
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Klaritromycin Merck may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Klaritromycin Merck in the following countries:
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Konaderm may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Konaderm in the following countries:
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Divitren may be available in the countries listed below.
Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Divitren in the following countries:
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Vitamina K Ecar may be available in the countries listed below.
Menadiol di(sodium sulfate) (a derivative of Menadiol) is reported as an ingredient of Vitamina K Ecar in the following countries:
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Belon may be available in the countries listed below.
Methylprednisolone 21-(sodium succinate) (a derivative of Methylprednisolone) is reported as an ingredient of Belon in the following countries:
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In the US, Kionex (sodium polystyrene sulfonate systemic) is a member of the drug class miscellaneous uncategorized agents and is used to treat Hyperkalemia.
US matches:
Polystyrene Sulfonic Acid sodium salt (a derivative of Polystyrene Sulfonic Acid) is reported as an ingredient of Kionex in the following countries:
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Glypressine may be available in the countries listed below.
Terlipressin is reported as an ingredient of Glypressine in the following countries:
Terlipressin diacetate (a derivative of Terlipressin) is reported as an ingredient of Glypressine in the following countries:
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Azathioprin-Puren may be available in the countries listed below.
Azathioprine is reported as an ingredient of Azathioprin-Puren in the following countries:
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Konakin MM Paediatric may be available in the countries listed below.
Phytomenadione is reported as an ingredient of Konakin MM Paediatric in the following countries:
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Pulmoterol may be available in the countries listed below.
Salmeterol is reported as an ingredient of Pulmoterol in the following countries:
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Ketamin-hameln may be available in the countries listed below.
Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Ketamin-hameln in the following countries:
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Definition of Dysautonomia: Dysautonomia is a general term used to describe a breakdown, or failure of the autonomic nervous system.
The following drugs and medications are in some way related to, or used in the treatment of Dysautonomia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
See sub-topics
In the US, Thiethylperazine (thiethylperazine systemic) is a member of the drug class phenothiazine antiemetics and is used to treat Nausea/Vomiting.
US matches:
Rec.INN
R06AD03
0001420-55-9
C22-H29-N3-S2
399
Antiemetic
10H-Phenothiazine, 2-(ethylthio)-10-[3-(4-methyl-1-piperazinyl)propyl]-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Ketoconazole Bevo may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Ketoconazole Bevo in the following countries:
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Dixin may be available in the countries listed below.
Alprazolam is reported as an ingredient of Dixin in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Rec.INN
R01AC02,S01GX02
0079516-68-0
C26-H29-F-N2-O2
420
Histamine, H₁-receptor antagonist
4-Piperidinecarboxylic acid, 1-[4-cyano-4-(4-fluorophenyl)cyclohexyl]-3-methyl-4-phenyl-, (-)-[1(cis),3α,4ß-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Cloxin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cloxacillin benzathine and sodium (a derivative of Cloxacillin) is reported as an ingredient of Cloxin in the following countries:
Cloxacillin sodium salt (a derivative of Cloxacillin) is reported as an ingredient of Cloxin in the following countries:
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Immergrun Ubichinone Q10 may be available in the countries listed below.
Ubidecarenone is reported as an ingredient of Immergrun Ubichinone Q10 in the following countries:
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Kinidin Durules may be available in the countries listed below.
Quinidine hydrogen sulfate (a derivative of Quinidine) is reported as an ingredient of Kinidin Durules in the following countries:
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Generic Name: benzoyl peroxide and urea topical (BEN zoe ill per OX ide and you REE ah)
Brand names: ZoDerm, ZoDerm Redi-Pads, Peroderm
Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away.
Urea is an emollient (skin softening agent). Urea helps to moisturize the skin.
Benzoyl peroxide and urea topical is used to treat acne.
Benzoyl peroxide and urea topical may also be used for purposes other than those listed in this medication guide.
Avoid combining sunscreen containing PABA and benzoyl peroxide. Temporary skin discoloration may occur if they are used together.
Avoid contact with clothing and hair. Benzoyl peroxide and urea topical may cause bleaching.
Use benzoyl peroxide and urea topical exactly as directed by your doctor, or follow the instructions on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
To use the cleanser, wet the skin and apply the cleanser to the affected area. Massage the medication gently into the skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry.
Wash your hands before and after application of the cream or gel.
Benzoyl peroxide and urea topical is usually applied once or twice daily. Follow your doctor's instructions.
Contact your doctor if you experience excessive skin burning, dryness, or irritation. Less frequent administration of the medication may be necessary.
Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.
It is important to use benzoyl peroxide and urea topical regularly to get the most benefit.
Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose.
Do not use other topical products on the same area at the same time unless directed to do so by your doctor. Other products may interfere with the effects or absorption of benzoyl peroxide and urea topical.
Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area being treated.
Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.
Avoid combining sunscreen containing PABA and benzoyl peroxide. Temporary skin discoloration may occur if they are used together.
Some skin burning, stinging, tingling, itching, redness, dryness, peeling, or irritation of the treated area may be experienced while using benzoyl peroxide and urea topical. Contact your doctor if these side effects are excessive. Less frequent application of benzoyl peroxide and urea topical may be necessary.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Acne:
Cream and gel: Apply to affected areas once or twice daily after washing with a mild cleanser and water.
Cleanser and pads: Apply to affected areas once or twice daily. Wet skin and apply to areas, massage gently into skin for 10 to 20 seconds and work into a lather, then rinse thoroughly and pat dry.
Do not use other topical products on the same area at the same time unless directed to do so by your doctor. Other products may interfere with the effects or absorption of benzoyl peroxide and urea topical.
Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area being treated.
Drugs other than those listed here may also interact with benzoyl peroxide and urea topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
See also: benzoyl peroxide and urea side effects (in more detail)
