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BACLOFEN 5 mg/mL Suspension

by Slayback Pharma LLC · 1 BOTTLE in 1 CARTON (71225-140-01) / 250 mL in 1 BOTTLE
NDC 71225-0140-01
🏷️ FDA NDC (as labeled) 71225-140-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 26, 2025 — Presence of Foreign Tablets/Capsules (Golden State Medical Supply Inc.) · FDA recall D-0235-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71225-140-01
Product NDC 71225-140
11-digit billing NDC 71225014001
NCPDP billing unit ML — per mL (volume)
RxCUI 2593376
UNII H789N3FKE8
Application # ANDA217252
SPL Set ID 9fad5ffc-afae-4c92-a672-ee636df45bc5
Established class (EPC) gamma-Aminobutyric Acid-ergic Agonist
Mechanism of action GABA A Agonists; GABA B Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-19
Route ORAL
Dosage form SUSPENSION
Substance BACLOFEN
GPI-14 75100010001825
GCN Seq No 083047
GCN 51885
HICL code 001949
Ingredient (HICL) Baclofen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.12.00
AHFS class Gaba-Derivative Skeletal Muscle Relaxant
FDB label name BACLOFEN 25 MG/5 ML SUSPENSION
FDB brand name Baclofen
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71225-140-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71225-0140-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the gamma-Aminobutyric Acid-ergic Agonist class.

Pharmacologic class gamma-Aminobutyric Acid-ergic Agonist
Drug family (ATC) Other centrally acting agents
How it works GABA B Agonists, GABA A Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSlayback Pharma LLC
Application holderANI PHARMACEUTICALS INC
FDA applicationANDA217252 (ANDA)
Labeler code71225
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BACLOFEN 25 MG/5 ML SUSPENSION Ingredient Baclofen
📗 Our plain-language guide HelloPharmacist
  • Baclofen is prescribed to reduce spasticity — the muscle stiffness, spasms, and rigidity that come with conditions like multiple sclerosis or spinal cord injury. Oral forms are als...
  • What exactly is baclofen being used to treat — and will it help my pain too?
  • Yes, and this is really important. Stopping baclofen suddenly — especially the pump form — can cause a dangerous withdrawal reaction: your spasticity can return much worse than bef...
  • I heard you can't just stop taking baclofen — is that really true?
📖 Read our full Baclofen guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $4.91 $1,228.60 / 250 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baclofen 5 mg/mL 52536-0600-11 Wilshire 1 bottle $3.768 AB Availability likely —
Baclofen 5 mg/mL 62559-0204-03 ANI 1 bottle $3.802 AB Availability likely —
Fleqsuvy 5 mg/mL 52652-6001-01 Azurity 1 bottle $5.982 AB Availability likely —
Baclofen 5 mg/mLthis 71225-0140-01 Slayback 1 bottle — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Baclofen — the program that covers self-administered drugs. 23 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Baclofen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$22.67M
Claims incl. refills
1.3M
Beneficiaries
744.4K
Spend / beneficiary
$30.45
Spend / claim
$17.31
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Baclofen — the ingredient across all brands.

Top reported reactions

Fatigue6,296
Pain5,852
Fall5,569
Nausea4,756
Headache4,525
Gait Disturbance4,179
Dizziness3,650

Reporter sex

0 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization28,757
Death6,566
Life-threatening2,815
Disabling2,171
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,707 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71225-0140-01 You're viewing this 1 BOTTLE in 1 CARTON (71225-140-01) / 250 mL in 1 BOTTLE 2023-06-19 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71225-140-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71225-0140-01, written without dashes as 71225014001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71225-0140-01, the first segment (71225) is the labeler code FDA assigned to Slayback Pharma LLC; the middle segment (0140) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Slayback Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Slayback Pharma LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 156 words ▾

1 INDICATIONS & USAGE Baclofen oral suspension is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. • Baclofen oral suspension is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

( 1 ) • Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE & ADMINISTRATION • Baclofen oral suspension is a concentrated formulation. Verify the dose of the product prior to dispensing. ( 2.1 ) • Initiate baclofen oral suspension with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) • The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.2 ) • When discontinuing, reduce the dosage slowly. ( 2.3 )

2.1Important Information Baclofen oral suspension is a concentrated formulation. Verify the strength and the dose of the product prior to prescribing, dispensing, and administering.

2.2Recommended Dosage Initiate baclofen oral suspension with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 1 mL (5 mg) three times a day for three days 2 mL (10 mg) three times a day for three days 3 mL (15 mg) three times a day for three days 4 mL (20 mg) three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily [4 mL (20 mg) four times a day].

2.3Administration Instructions Shake well baclofen oral suspension before administration. Discard unused portion 2 months after first opening. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

2.4Discontinuation of baclofen oral suspension When discontinuing baclofen oral suspension, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [ see Warnings and Precautions ( 5.1 ) ].

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS & STRENGTHS Oral Suspension: 25 mg per 5 mL (5 mg/mL) baclofen as a concentrated white to off white, grape-flavored suspension. Oral Suspension: 25 mg per 5 mL (5 mg/mL) ( 3 )

⛔ Contraindications 20 words ▾

4 CONTRAINDICATIONS Baclofen oral suspension is contraindicated in patients with hypersensitivity to baclofen. • Hypersensitivity to baclofen ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen oral suspension is discontinued. ( 5.1 ) • Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen oral suspension before delivery. ( 5.2 ) • Baclofen oral suspension can cause drowsiness and sedation.

Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen oral suspension may be additive to those of alcohol and other CNS depressants. ( 5.3 ) • Baclofen oral suspension can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy.

Use with caution in patients with these conditions. ( 5.5 , 5.6 , 5.7 )

5.1Adverse Reactions from Abrupt Withdrawal of baclofen oral suspension Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when baclofen oral suspension is discontinued, unless the clinical situation justifies a rapid withdrawal.

5.2Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and baclofen oral suspension is continued during pregnancy, gradually reduce the dosage and discontinue baclofen oral suspension before delivery.

If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal.

5.3Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in baclofen oral suspension [ see Adverse Reactions ( 6.1 ) ]. Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting baclofen oral suspension or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen oral suspension may be additive to those of alcohol and other CNS depressants.

5.4Poor Tolerability in Stroke Patients Baclofen oral suspension should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

5.5Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Baclofen oral suspension should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen oral suspension, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.

5.6Exacerbation of Autonomic Dysreflexia Baclofen oral suspension should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen oral suspension may cause an autonomic dysreflexic episode.

5.7Exacerbation of Epilepsy Baclofen oral suspension should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen.

5.8Posture and Balance Effects Baclofen oral suspension should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locom…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Adverse Reactions from Abrupt Withdrawal of baclofen oral suspension [ see Warnings and Precautions ( 5.1 ) ] • Neonatal Withdrawal Symptoms [ see Warnings and Precautions ( 5.2 ) ] • Drowsiness and Sedation [ see Warnings and Precautions ( 5.3 ) ] • Poor Tolerability in Stroke Patients [ see Warnings and Precautions ( 5.4 ) ] • Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [ see Warnings and Precautions ( 5.5 ) ] • Exacerbation of Autonomic Dysreflexia [ see Warnings and Precautions ( 5.6 ) ] • Exacerbation of Epilepsy [ see Warnings and Precautions ( 5.7 ) ] • Posture and Balance Effects [ see Warnings and Precautions ( 5.8 ) ] • Ovarian Cysts [ see Warnings and Precautions ( 5.9 ) ] • The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slayback Pharma at 1-844-566-2505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group.

Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1. Table 1.

Common (≥1%) Adverse Reactions in Patients Treated with baclofen for Spasticity ADVERSE REACTION PERCENT Drowsiness 10-63% Dizziness 5-15% Weakness 5-15% Nausea 4-12% Confusion 1-11% Hypotension 0-9% Headache 4-8% Insomnia 2-7% Constipation 2-6% Urinary Frequency 2-6% Fatigue 2-4% The following adverse reactions not included in Table 1, classified by body system, were also reported: Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

🔄 Drug Interactions 39 words ▾

7 DRUG INTERACTIONS

7.1CNS Depressants and Alcohol Baclofen oral suspension can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) • Because baclofen is excreted unchanged through the kidneys it may be necessary to reduce the dosage in patients with impaired renal function. ( 8.6 )

8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen oral suspension in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery ( see Clinical Considerations ). Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen oral suspension may increase the risk of late-onset neonatal withdrawal symptoms [ see Warnings and Precautions ( 5.2 ) ].

Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.

8.2Lactation Risk Summary At recommended oral doses, baclofen is present in human milk. There are no human data on the effects of baclofen on milk production. Withdrawal symptoms can occur in breastfed infants when maternal administration of baclofen oral suspension is stopped, or when breastfeeding is stopped [ see Warnings and Precautions ( 5.2 ) ].

There are no adequate data on other effects of baclofen on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for baclofen oral suspension and any potential adverse effects on the breastfed infant from baclofen oral suspension or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [ see Use in Specific Populations ( 8.6 ) ].

8.6Renal Impairment Because baclofen is primarily excreted unchanged through the kidneys, baclofen oral suspension should be given with caution to patients with renal impairment, and it may be necessary to reduce the dosage.

🤰 Pregnancy 211 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen oral suspension in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery ( see Clinical Considerations ). Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen oral suspension may increase the risk of late-onset neonatal withdrawal symptoms [ see Warnings and Precautions ( 5.2 ) ].

Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams. This abnormality was not seen in mice or rabbits.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.

🧓 Geriatric Use 109 words ▾

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [ see Use in Specific Populations ( 8.6 ) ].

🆘 Overdosage 53 words ▾

10 OVERDOSAGE

10.1Symptoms of baclofen Overdose With overdose of baclofen, patients may present in coma or with progressive drowsiness, lightheadedness, dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness.

10.2Treatment for Overdose The treatment of baclofen overdose includes gastric decontamination, maintaining an adequate airway and respirations.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma- aminobutyric acid (GABA) and may exert its effects by stimulation of the GABA B receptor subtype.

12.2Pharmacodynamics Baclofen has been shown to have general CNS depressant properties, as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression [ see Warnings and Precautions ( 5.3 ), Adverse Reactions (6.1), and Overdosage ( 10.1 ) ].

12.3Pharmacokinetics A pharmacokinetic study in heathy adult male and female subjects under fasting conditions at 20 mg dose level demonstrated similar bioavailability for baclofen oral suspension and oral tablets. Absorption The peak plasma concentrations of baclofen were achieved in about 1 hour from administration of baclofen oral suspension in the fasted state, and the apparent elimination half-life is about 5.6 hours. Effect of Food Administration of baclofen oral suspension with a high-fat meal resulted in 9% decrease in AUC and 33% decrease in C max compared to the fasted state.

Elimination Baclofen is excreted primarily by the kidney in unchanged form, and there is relatively large intersubject variation in absorption and/or elimination.

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma- aminobutyric acid (GABA) and may exert its effects by stimulation of the GABA B receptor subtype.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Baclofen oral suspension contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a white to off white viscous suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and tamper evident band. 250 mL, NDC 71225-140-01

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° and 30° (59° and 86° F) (see USP Controlled Room Temperature). Discard unused portion 2 months after first opening.

📋 Description 107 words ▾

11 DESCRIPTION Baclofen oral suspension is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 CINO 2 . Molecular Weight is 213.66 g/mol.

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral suspension inactive ingredients are artificial grape flavor, hydrochloric acid, hypromellose, methyl paraben, propyl paraben, purified water, simethicone emulsion, sodium hydroxide, sucralose and xanthan gum.

Baclofen structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Inform patients that baclofen oral suspension is a concentrated formulation. Instruct patients or caregivers to use an oral dosing syringe and not to use a household teaspoon to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy.

Instruct patients to shake before using [ see Dosage and Administration ( 2.1 , 2.3 ) ]. Risks Related to Sudden Withdrawal of baclofen oral suspension Advise patients and caregivers not to discontinue use of baclofen oral suspension without consulting with their healthcare provider because sudden withdrawal of baclofen oral suspension can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death [ see Warnings and Precautions ( 5.1 ) ].

Inform patients that early symptoms of baclofen oral suspension withdrawal may include increased spasticity, itching, and tingling of extremities. Neonatal Withdrawal Symptoms Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed [ see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.2 ) ]. Increased Risk of Drowsiness with Alcohol and Other CNS Depressants Advise patients that baclofen oral suspension may cause drowsiness, and that they should avoid the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness when starting baclofen oral suspension or increasing the dose until they know how the drug affects them [ see Warnings and Precautions ( 5.3 ) ].

Inform patients and their caregivers that the drowsiness associated with baclofen oral suspension use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their healthcare provider about all prescription and nonprescription drugs they may use. Storage Instruct patients to store baclofen oral suspension at room temperature and to discard unused portion 2 months after first opening [ see How Supplied/Storage and Handling ( 16.2 ) ].

Manufactured for: Slayback Pharma LLC, Princeton, NJ 08540. Manufactured at: Bora Pharmaceutical Services Inc 7333 Mississauga Rd, Mississauga, Ontario L5N 6L4, Canada (CAN) Revised: 12/2022

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71225-0126-04 · Slayback 71227-0001-01 · TIMS →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.